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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
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☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2022
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☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from _____ to
____ .
Commission File Number: 001-39614
TARSUS PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
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Delaware |
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81-4717861 |
(State or other jurisdiction of
incorporation or organization) |
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(I.R.S. Employer
Identification Number) |
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15440 Laguna Canyon Road, Suite 160 |
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Irvine, California
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92618 |
(Address of principal executive offices) |
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(Zip Code) |
(949) 409-9820
(Registrant's telephone number, including area code)
Securities registered pursuant to Section 12(b) of the
Act:
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Title of each class |
Trading Symbol |
Name of each exchange on which registered |
Common Stock, $0.0001 par value per share |
TARS |
The Nasdaq Global Market LLC
(Nasdaq Global Select Market)
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Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes ☒ No ☐
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files).
Yes ☒ No ☐
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer |
☐ |
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Accelerated filer |
☐ |
Non-accelerated filer |
☒ |
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Smaller reporting company |
☒ |
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Emerging growth company |
☒ |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☒
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
20,727,701 shares of common stock, $0.0001 par value, outstanding
as of May 4, 2022.
TABLE OF CONTENTS
PART I—FINANCIAL INFORMATION
Item I. Financial Statements (Unaudited)
TARSUS PHARMACEUTICALS, INC.
INDEX TO THE FINANCIAL STATEMENTS
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Pages |
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F-2 |
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F-3 |
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F-4 |
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F-5 |
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F-6 |
TARSUS PHARMACEUTICALS, INC.
CONDENSED BALANCE SHEETS
(In thousands, except share and par value amounts)
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March 31, 2022 |
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December 31, 2021 |
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(unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
$ |
175,010 |
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$ |
171,332 |
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Marketable securities |
291 |
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483 |
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Accounts receivable |
17 |
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— |
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Other receivables |
306 |
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92 |
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Prepaid expenses and other current assets |
3,131 |
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4,045 |
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Total current assets |
178,755 |
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175,952 |
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Property and equipment, net |
915 |
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755 |
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Operating lease right-of-use assets |
926 |
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1,074 |
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Other assets |
887 |
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1,126 |
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Total assets |
$ |
181,483 |
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$ |
178,907 |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable and other accrued liabilities |
$ |
10,805 |
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$ |
8,680 |
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Accrued payroll and benefits |
1,805 |
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2,798 |
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Total current liabilities |
12,610 |
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11,478 |
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Term loan, net |
19,180 |
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— |
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Other long-term liabilities |
496 |
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699 |
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Total liabilities |
32,286 |
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12,177 |
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Commitments and contingencies (Note
8)
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value; 10,000,000 authorized; no
shares issued and outstanding at March 31, 2022 and
December 31, 2021
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized;
20,731,062 shares issued and 20,718,528 outstanding, which excludes
12,534 shares subject to repurchase at March 31, 2022
(unaudited); 20,726,580 shares issued and 20,698,737 outstanding,
which excludes 27,840 shares subject to repurchase at
December 31, 2021
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4 |
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Additional paid-in capital |
216,103 |
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213,398 |
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Accumulated deficit |
(66,910) |
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(46,672) |
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Total stockholders’ equity |
149,197 |
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166,730 |
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Total liabilities and stockholders’ equity |
$ |
181,483 |
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$ |
178,907 |
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See accompanying notes to these unaudited condensed financial
statements.
TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE (LOSS)
INCOME
(Unaudited)
(In thousands, except share and per share amounts)
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Three Months Ended
March 31, |
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2022 |
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2021 |
Revenues: |
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License fees |
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$ |
— |
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$ |
33,311 |
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Collaboration revenue |
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539 |
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121 |
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Total revenues |
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539 |
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33,432 |
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Operating expenses: |
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Cost of license fees and collaboration revenue |
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33 |
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1,297 |
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Research and development |
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12,081 |
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16,261 |
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General and administrative |
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7,946 |
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5,160 |
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Total operating expenses |
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20,060 |
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22,718 |
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(Loss) income from operations before other (expense) income and
income taxes |
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(19,521) |
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10,714 |
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Other (expense) income: |
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Interest (expense) income, net |
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(316) |
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9 |
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Other income (expense), net |
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37 |
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(34) |
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Unrealized loss on equity securities |
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(192) |
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— |
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Change in fair value of equity warrants |
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(245) |
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— |
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Total other expense, net |
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(716) |
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(25) |
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Benefit for income taxes |
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(1) |
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(313) |
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Net (loss) income and comprehensive (loss) income |
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$ |
(20,238) |
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$ |
10,376 |
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Net (loss) per share, basic |
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$ |
(0.98) |
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$ |
(0.51) |
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Net (loss) income per share, diluted |
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$ |
(0.98) |
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$ |
0.47 |
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Weighted-average shares outstanding, basic |
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20,710,224 |
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20,336,022 |
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Weighted-average shares outstanding, diluted |
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20,710,224 |
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21,824,574 |
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See accompanying notes to these unaudited condensed financial
statements.
TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF PREFERRED STOCK AND STOCKHOLDERS’
EQUITY
(Unaudited)
(In thousands, except share data)
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Preferred Stock |
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Common Stock |
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Additional Paid-In Capital |
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Accumulated
Deficit |
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Total
Stockholders’
Equity |
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Shares |
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Amount |
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Shares |
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Amount |
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Balance as of December 31, 2021 |
— |
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$ |
— |
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20,698,737 |
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$ |
4 |
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$ |
213,398 |
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$ |
(46,672) |
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$ |
166,730 |
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Net loss |
— |
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— |
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— |
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— |
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— |
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(20,238) |
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(20,238) |
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Recognition of stock-based compensation expense |
— |
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— |
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— |
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— |
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2,674 |
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— |
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2,674 |
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Exercise of vested stock options |
— |
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— |
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225 |
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— |
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— |
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— |
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— |
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Issuance of common stock upon the vesting of restricted stock
units |
— |
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— |
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4,257 |
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— |
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— |
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— |
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— |
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Lapse of repurchase rights related to common stock issued pursuant
to stock option exercises prior to vesting |
— |
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— |
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15,309 |
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— |
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31 |
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— |
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31 |
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Balance as of March 31, 2022 |
— |
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$ |
— |
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20,718,528 |
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$ |
4 |
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$ |
216,103 |
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$ |
(66,910) |
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$ |
149,197 |
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|
|
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|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock |
|
Common Stock |
|
Additional Paid-In Capital |
|
Accumulated
Deficit |
|
Total
Stockholders’
Deficit |
|
Shares |
|
Amount |
|
Shares |
|
Amount |
|
|
Balance as of December 31, 2020 |
— |
|
|
$ |
— |
|
|
20,323,201 |
|
|
$ |
4 |
|
|
$ |
198,821 |
|
|
$ |
(32,845) |
|
|
$ |
165,980 |
|
Net income |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
10,376 |
|
|
10,376 |
|
Recognition of stock-based compensation expense |
— |
|
|
— |
|
|
— |
|
|
— |
|
|
1,363 |
|
|
— |
|
|
1,363 |
|
Exercise of vested stock options |
— |
|
|
— |
|
|
13,773 |
|
|
— |
|
|
19 |
|
|
— |
|
|
19 |
|
Shares issued as consideration for in-license rights |
— |
|
|
— |
|
|
187,500 |
|
|
— |
|
|
5,494 |
|
|
— |
|
|
5,494 |
|
Balance as of March 31, 2021 |
— |
|
|
$ |
— |
|
|
20,524,474 |
|
|
$ |
4 |
|
|
$ |
205,697 |
|
|
(22,469) |
|
|
$ |
183,232 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
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|
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|
|
|
|
|
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|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
See accompanying notes to these unaudited condensed financial
statements.
TARSUS PHARMACEUTICALS, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2022 |
|
2021 |
Cash Flows From Operating Activities: |
|
|
|
Net (loss) income |
$ |
(20,238) |
|
|
$ |
10,376 |
|
Adjustments to reconcile net (loss) income to net cash used in
operating activities: |
|
|
|
Depreciation and amortization |
41 |
|
|
64 |
|
Amortization and accretion of long-term debt related
costs |
55 |
|
|
— |
|
Stock-based compensation |
2,674 |
|
|
1,363 |
|
Non-cash lease expense |
113 |
|
|
43 |
|
Loss on disposal of property and equipment |
— |
|
|
70 |
|
Loss on lease termination |
— |
|
|
2 |
|
Unrealized loss on equity securities |
192 |
|
|
— |
|
Change in fair value of equity warrants |
245 |
|
|
— |
|
|
|
|
|
Unrealized loss (gain) from transactions denominated in a foreign
currency |
1 |
|
|
(35) |
|
Issuance of common stock pursuant to in-license
agreement |
— |
|
|
5,494 |
|
Changes in operating assets and liabilities: |
|
|
|
Accounts receivable |
(17) |
|
|
(25,000) |
|
Contract asset |
— |
|
|
(7,199) |
|
Other receivables |
(225) |
|
|
(227) |
|
Prepaid expenses and other current assets |
926 |
|
|
(321) |
|
Other non-current assets |
14 |
|
|
(1,255) |
|
Accounts payable and other accrued liabilities |
1,969 |
|
|
5,063 |
|
Accrued payroll and benefits |
(993) |
|
|
(355) |
|
Other long-term liabilities |
(43) |
|
|
123 |
|
Net cash used in operating activities |
(15,286) |
|
|
(11,794) |
|
Cash Flows From Investing Activities: |
|
|
|
Purchases of property and equipment |
(161) |
|
|
(175) |
|
Cash used in investing activities |
(161) |
|
|
(175) |
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
|
Proceeds from exercise of vested stock options |
— |
|
|
19 |
|
Payment of deferred offering costs
|
(60) |
|
|
— |
|
|
|
|
|
|
|
|
|
Proceeds from term loan |
20,000 |
|
|
— |
|
Payment of debt issuance costs |
(815) |
|
|
— |
|
|
|
|
|
Net cash provided by financing activities |
19,125 |
|
|
19 |
|
Net decrease in cash, cash equivalents and restricted
cash |
3,678 |
|
|
(11,950) |
|
Cash, cash equivalents, and restricted cash — beginning of
period |
171,332 |
|
|
168,149 |
|
Cash, cash equivalents, and restricted cash — end of
period |
$ |
175,010 |
|
|
$ |
156,199 |
|
Reconciliation of cash, cash equivalents and restricted
cash |
|
|
|
Cash and cash equivalents |
$ |
175,010 |
|
|
$ |
156,179 |
|
Restricted cash |
— |
|
|
20 |
|
Cash, cash equivalents and restricted cash |
$ |
175,010 |
|
|
$ |
156,199 |
|
Supplemental Disclosures Noncash Investing and Financing
Activities: |
|
|
|
|
|
|
|
"Interest expense" paid in cash |
$ |
127 |
|
|
$ |
— |
|
Additions of "property and equipment, net" included within
"accounts payable and other accrued liabilities" |
$ |
41 |
|
|
$ |
— |
|
Expensing of "operating lease right-of-use assets" upon lease
termination |
$ |
— |
|
|
$ |
(38) |
|
Stock issued for in-license agreements |
$ |
— |
|
|
$ |
5,494 |
|
|
|
|
|
Deferred offering costs included within "accounts payable and
accrued liabilities" |
$ |
55 |
|
|
$ |
— |
|
See accompanying notes to these unaudited condensed financial
statements.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
1. DESCRIPTION OF BUSINESS AND PRESENTATION OF FINANCIAL
STATEMENTS
(a) Description of Business
Tarsus Pharmaceuticals, Inc. (“Tarsus” or the “Company”) is a
biopharmaceutical company focused on the development and
commercialization of therapeutics, starting with eye
care.
(b) Liquidity
The Company has no product sales and has accumulated losses and
negative cash flows from operations since inception (other than
consideration received from an out-licensing agreement, as
discussed in
Note 9),
resulting in an accumulated deficit of $66.9 million as of
March 31, 2022 and $46.7 million as of December 31, 2021.
The Company’s cash and cash equivalents were $175.0 million and
$171.3 million as of March 31, 2022 and December 31,
2021, respectively. The Company expects to continue to incur
operating losses and negative cash flows.
On February 2, 2022, the Company executed a loan and security
agreement (the "Credit Facility") with Hercules Capital, Inc.
("Hercules") and Silicon Valley Bank ("SVB"). This
$175 million Credit Facility has tranched availability.
Capital draws are at the Company's election and are in
$5 million increments. In February 2022, the Company made a
$20 million draw (see
Note 10).
The Company has funded its inception-to-date operations primarily
through equity capital raises, proceeds from its out-license
agreement, and draw downs on its credit facility. The Company
estimates that its existing capital resources will be sufficient to
meet projected operating requirements beyond at least 12 months
from the filing date of the accompanying Condensed Financial
Statements in this Form 10-Q. Accordingly, the accompanying
financial statements in this Form 10-Q have been prepared on a
going concern basis, which contemplates the realization of assets
and satisfaction of liabilities in the normal course of
business.
The Company’s operations currently consist of its corporate
organization build-out, intellectual property licensing activities,
and preclinical and clinical study progression. The Company faces
the clinical, business, and liquidity risks that are typically
associated with biopharma companies; it must significantly invest
in and conduct research and development activities, achieve
research and development outcomes that are inherently uncertain,
recruit and retain skilled personnel (including executive
management), and expand and defend its intellectual property
rights.
Management expects the Company to continue to incur losses in the
foreseeable future as a result of research and development
activities and other operating expenses. The Company may be
required to raise additional capital to fund its future operations.
However, no assurance can be given as to whether financing will be
available on terms acceptable to the Company, if at all. If the
Company raises additional funds by issuing equity securities, its
stockholders may experience dilution. The Company's Credit Facility
imposes additional covenants that restrict operations, including
limitations on its ability to incur liens or additional debt, pay
dividends, repurchase common stock, make certain investments, or
engage in certain merger or asset sale transactions. Any debt
financing or additional equity raise may contain terms that are not
favorable to the Company or its stockholders. The Company’s
potential inability to raise capital when needed could have a
negative impact on its financial condition and ability to pursue
planned business strategies. If the Company is unable to raise
additional funds as required, it may need to delay, reduce, or
terminate some or all its development programs and clinical trials.
The Company may also be required to sell or license its rights to
product candidates in certain territories or indications that it
would otherwise prefer to develop and commercialize on its own. If
the Company is required to enter into collaborations and other
arrangements to address its liquidity needs, it may have to give up
certain rights that limit its ability to develop and commercialize
product candidates or may have other terms that are not favorable
to the Company or its stockholders, which could materially and
adversely affect its business and financial prospects. These
factors may adversely impact the Company's ability to achieve its
business objectives and would likely have an adverse effect on its
future business prospects, or even its ability to remain a going
concern.
(c) Operating Segment
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
To date, the Company has operated and managed its business and
financial information on an aggregate basis based on the Company's
organizational structure, for the purposes of evaluating financial
performance and the allocation of capital and personnel resources,
consistent with the way operations and investments are centrally
managed and evaluated. Accordingly, the Company’s management
determined that it operates one reportable operating segment. This
single segment is focused exclusively on developing pharmaceutical
products for eventual commercialization.
(d) Emerging Growth Company Status
The Company is an "emerging growth company," as defined in the
Jumpstart Our Business Startups Act of 2012 (the "JOBS Act"). Under
the JOBS Act, emerging growth companies can delay adopting new or
revised accounting standards issued subsequent to the enactment of
the JOBS Act until such time as those standards apply to private
companies. The Company has irrevocably elected to not take this
exemption. As a result, it will adopt new or revised accounting
standards on the relevant effective dates on which adoption of such
standards is required for other public companies that are not
emerging growth companies.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES AND USE OF
ESTIMATES
(i) Basis of Presentation
The Company’s Condensed Financial Statements have been prepared in
conformity with accounting principles generally accepted ("GAAP")
in the United States ("U.S.") for interim financial information and
pursuant to Form 10-Q and with the rules and regulations
of the Securities and Exchange Commission ("SEC"). Accordingly, the
accompanying Condensed Financial Statements do not include all of
the information and footnotes required by GAAP for complete
financial statements.
The interim Condensed Balance Sheet as of March 31, 2022, the
interim Condensed Statements of Operations and Comprehensive (Loss)
Income, and Stockholders’ Equity for the three months ended
March 31, 2022 and 2021, and the interim Condensed Cash Flows
for the three months ended March 31, 2022 and 2021 are
unaudited. These unaudited interim financial statements have been
prepared on the same basis as the Company’s annual financial
statements and, in the opinion of management, reflect all
adjustments, which consist of only normal and recurring adjustments
for the fair presentation of its financial
information.
The financial data and other information disclosed in these notes
related to the three-month periods are also unaudited. The
Condensed Balance Sheet as of December 31, 2021 has been derived
from the audited financial statements at that date but does not
include all information and footnotes required by GAAP for annual
financial statements. The condensed interim operating results for
three months ended March 31, 2022 are not necessarily
indicative of results to be expected for the year ending
December 31, 2022 or any other interim or annual
period.
The accompanying interim unaudited Condensed Financial Statements
should be read in conjunction with the audited financial statements
and the related notes thereto in the Company’s Annual Report on
Form 10-K for the year ended December 31, 2021, as filed with
the SEC on March 14, 2022.
The preparation of financial statements in conformity with GAAP and
with the rules and regulations of the SEC requires management to
make informed estimates and assumptions that affect the amounts
reported in these financial statements and accompanying notes.
These estimates and assumptions involve judgments with respect to
numerous factors that are difficult to forecast and may materially
differ from the amounts ultimately realized and reported due to the
inherent uncertainty of any estimate or assumption.
There have been no significant changes in the Company’s significant
accounting policies during the three months ended March 31,
2022, as compared with those disclosed in its Annual Report on Form
10-K for the year ended December 31, 2021 filed with the SEC
on March 14, 2022. The accounting policies and estimates that most
significantly impact the presented amounts within the accompanying
Condensed Financial Statements are further described
below:
(ii) Cash and Cash Equivalents
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
Cash and cash equivalents consist of bank deposits and highly
liquid investments, including money market fund accounts, that are
readily convertible into cash without penalty, with original
maturities of three months or less from the purchase
date.
(iii) Marketable Securities
Marketable securities represent LianBio Ophthalmology Limited
("LianBio") common stock (see
Note 7)
designated as "available-for-sale securities" with associated gains
or losses recorded within "other expense, net" within the Condensed
Statements of Operations at each reporting period.
(iv) Concentration of Credit Risk and Other Risks and
Uncertainties
Financial instruments that potentially subject the Company to
significant concentrations of credit risk consist primarily of cash
and cash equivalents in deposits at financial institutions that
exceed federally insured limits.
In March 2020, the World Health Organization declared a pandemic
related to the global novel coronavirus disease 2019 (“COVID-19”)
outbreak. The COVID-19 pandemic continues to evolve and its impact
on the Company’s business will depend on several factors that are
highly uncertain and unpredictable, including, the efficacy and
adoption of vaccines, future resurgences of the virus and its
variants, and the speed at which government restrictions are
lifted. To date, the Company’s operations have not been
significantly impacted by the COVID-19 pandemic, though the Company
continues to monitor the potential impact COVID-19 may have on its
ongoing and planned clinical trials. However, the Company cannot at
this time predict the specific extent, duration, or full impact
that the COVID-19 outbreak may have on these activities or its
financial condition.
The Company’s results of operations involve numerous risks and
uncertainties. Factors that could adversely impact the Company’s
operating results and business objectives include, but are not
limited to, (1) uncertainty of results of clinical trials, (2)
uncertainty of regulatory approval of the Company’s potential
product candidates, (3) uncertainty of market acceptance of its
product candidates, (4) competition from substitute products and
other companies, (5) securing and protecting proprietary technology
and strategic relationships, and (6) dependence on key individuals
and sole source suppliers.
The Company’s product candidates require approvals from the U.S.
Food and Drug Administration (“FDA”) and comparable foreign
regulatory agencies prior to commercial sales in their respective
jurisdictions. There can be no assurance that any product
candidates will receive the necessary approvals. If the Company is
denied approval, approval is delayed or the Company is unable to
maintain approval for any product candidate, it could have a
materially adverse impact on the business.
(v) Revenue Recognition for Out-License Arrangements
Overview
The Company currently has one out-license arrangement that allows
the third-party licensee to market the its TP-03 product candidate
(representing "functional intellectual property") in certain
territories for a certain field of use and for a stated term -
see
Note 9.
The accounting and reporting of revenue for out-license
arrangements requires significant judgment for: (a) identification
of the number of performance obligations within the contract, (b)
the contract’s transaction price for allocation (including variable
consideration), (c) the stand-alone selling price for each
identified performance obligation, and (d) the timing and amount of
revenue recognition in each period.
The Company's out-license arrangement, as described in
Note 9,
was analyzed under GAAP to determine whether the promised goods or
services (which include the license, and know-how, data, and
information necessary or reasonably useful for the research,
development, manufacture, or commercialization of any license
product, and governance committee services) are distinct or must be
accounted for as part of a combined performance obligation. In
making these assessments, the Company considers factors such as the
stage of development of the underlying intellectual property and
the capabilities of the customer to develop the intellectual
property on their own, and/or whether the required expertise is
readily available. If the license is considered to not be distinct,
the license is combined with other promised goods or services as a
combined performance obligation for revenue
recognition.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
The Company's out-license arrangement includes the following forms
of consideration: (i) non-refundable upfront license payments, (ii)
equity-based consideration, (iii) sales-based royalties, (iv) sales
threshold milestones, (v) development milestone payments, and (vi)
regulatory milestone payments. Revenue is recognized in proportion
to the allocated transaction price when (or as) the respective
performance obligation is satisfied. The Company evaluates the
progress related to each milestone at each reporting period and, if
necessary, also adjusts the probability of achievement and related
revenue recognition. The measure of progress, and thereby periods
over which revenue is recognized, is subject to estimates by
management and may change over the course of the
agreement.
Contractual Terms for Receipt of Payments
The contractual terms that establish the Company’s right to collect
specified amounts from its customers and that require
contemporaneous evaluation and documentation under GAAP for the
corresponding timing and amount of revenue recognition, are as
follows:
(1)
Upfront License Fees:
The Company determines whether non-refundable license fee
consideration is recognized at the time of contract execution
(i.e., when the license is transferred to the customer and customer
is able to use and benefit from the license) or over the actual (or
implied) contractual period of the out-license. The Company also
evaluates whether it has any other requirements to provide
substantive services that are inseparable from the performance
obligation of the license transfer to determine whether any
combined performance obligation is satisfied over time or at a
point in time. Upfront payments may require deferral of revenue
recognition to a future period until the Company performs
obligations under these arrangements.
(2)
Development Milestones:
The Company utilizes the “most likely amount” method to estimate
the amount of consideration to which it will be entitled for
achievement of development milestones as these represent variable
consideration. For those payments based on development milestones
(e.g., patient dosing in a clinical study or the achievement of
statistically significant clinical results), the Company assesses
the probability that the milestone will be achieved, including its
ability to control the timing or likelihood of achievement, and any
associated revenue constraint. Given the high degree of uncertainty
around the occurrence of these events, the Company determined the
milestone and other contingent amounts to be "constrained" until
the uncertainty associated with these payments is resolved. At each
reporting period, the Company re-evaluates this associated revenue
recognition constraint. Any resulting adjustments are recorded to
revenue on a cumulative catch-up basis, and reflected in the
financial statements in the period of adjustment.
(3)
Regulatory Milestones:
The Company utilizes the “most likely amount” method to estimate
the consideration to which it will be entitled and recognizes
revenue in the period regulatory approval occurs (the performance
obligation is satisfied) as these represent variable consideration.
Amounts constrained as variable consideration are included in the
transaction price to the extent that it is probable that a
significant reversal in the amount of cumulative revenue recognized
will not occur when the uncertainty associated with the variable
consideration is subsequently resolved. The Company evaluates
whether the milestones are considered probable of being reached and
not otherwise constrained. Accordingly, due to the inherent
uncertainty of achieving regulatory approval, associated milestones
are constrained for revenue recognition until
achievement.
(4)
Royalties:
Under the "sales-or-usage-based royalty exception" the Company
recognizes revenue based on the contractual percentage of the
licensee’s sale of products to its customers at the later of (i)
the occurrence of the related product sales or (ii) the date upon
which the performance obligation to which some or all of the
royalty has been allocated has been satisfied or partially
satisfied. To date, the Company has not recognized any royalty
revenue from its out-licensing arrangements.
(5)
Sales Threshold Milestones:
Similar to royalties, applying the "sales-or-usage-based royalty
exception", the Company recognizes revenue from sales threshold
milestones at the later of (i) the period the licensee achieves the
one-time annual product sales levels in their territories for which
the Company is contractually entitled to a specified lump-sum
receipt, or (ii) the date upon which the performance obligation to
which some or all of the milestone has been allocated has been
satisfied or partially satisfied. To date, the Company has not
recognized any sales threshold milestone revenue from out-licensing
arrangements.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
The Company re-evaluates the measure of progress to each
performance obligation in each reporting period as uncertain events
are resolved and other changes in circumstances occur. A
"performance obligation" is a promise in a contract to transfer a
distinct good or service and is the unit of accounting. A
contract’s "transaction price" is allocated among each distinct
performance obligation based on relative standalone selling price
and recognized when, or as, the applicable performance obligation
is satisfied.
(vi) Research and Development Costs
Research and development costs are expensed as incurred or as
certain upfront or milestone payments become contractually due to
licensors upon the achievement of clinical or regulatory events.
These expenses also include internal costs directly attributable to
in-development programs, including cost of certain salaries,
payroll taxes, employee benefits, and stock-based compensation
expense, as well as laboratory and clinical supplies, pre-clinical
and clinical trial related expenses, clinical manufacturing costs,
and the cost of services provided by outside contractors. The
Company recognizes expense for pre-clinical studies and clinical
trial activities performed by these third parties. This is
typically based upon estimates of the proportion of work completed
over the term of the individual study or trial, as well as patient
enrollment and dosing events in accordance with agreements
established with clinical research organizations ("CROs") and
clinical trial or pre-clinical study sites.
The Company has entered, and may continue to enter into, license
agreements to access and utilize intellectual property for drug
development. In each case, the Company evaluates if the assets
acquired in a transaction represent the acquisition of an
asset
or a business, as defined under applicable GAAP. The Company’s
executed in-license agreements (see
Note 8(b))
were evaluated and determined to represent asset acquisitions.
Because these assets have not yet received regulatory
approval
and have no alternative future use, the purchase price for each was
immediately recognized as research and development expense. In
addition, any future milestone payments (whether in the form of
cash or stock) made before product regulatory approval (that do not
meet the definition of a derivative) will also be immediately
recognized as research and development expense when paid or becomes
payable, provided there is no alternative future use of the rights
in other research and development projects.
(vii) Stock-Based Compensation
The Company recognizes stock-based compensation expense for equity
awards granted to employees, consultants, and members of its Board
of Directors. The Black-Scholes pricing model is used to estimate
the fair value of stock option awards as of the date of grant. The
fair value of restricted stock units is representative of the
closing share price preceding the date of grant.
For stock-based awards that vest subject to the satisfaction of a
service requirement, the related expense is recognized on a
straight-line basis over each award’s actual or implied vesting
period. For stock-based awards that vest subject to a performance
condition, the Company recognizes related expense on an accelerated
attribution method, if and when it concludes that it is highly
probable that the performance condition will be achieved. As
applicable, the Company reverses previously recognized expense for
forfeitures of unvested awards in the same period of
occurrence.
The measurement of the fair value of stock option awards and
recognition of stock-based compensation expense requires
assumptions to be estimated by management that involve inherent
uncertainties and the application of management’s judgment,
including (a) the fair value of the Company’s common stock on
the date of the option grant for all awards granted prior to the
Initial Public Offering ("IPO"), (b) the expected term of the
stock option until its exercise by the recipient, (c) stock
price volatility over the expected term, (d) the prevailing
risk-free interest rate over the expected term, and
(e) expected dividend payments over the expected
term.
Management estimates the expected term of awarded stock options
utilizing the “simplified method” for awards as the Company does
not yet have sufficient exercise history since its November 2016
corporate formation. The Company lacks company-specific historical
and implied volatility information of its stock. Accordingly,
management estimated this expected volatility based on a designated
peer-group of publicly-traded companies for a look-back period, as
of the date of grant, that corresponded with the expected term of
the awarded stock option. The Company estimates the risk-free
interest rate based upon the U.S. Department of the Treasury yield
curve in effect at award grant for time periods that correspond
with the expected term
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
of the awarded stock option. The Company’s expected dividend yield
is zero because it has never paid cash dividends and does not
expect to for the foreseeable future.
The fair value of the Company’s common stock is based on the
closing quoted market price of its common stock as reported by the
Nasdaq Global Select Market on the date of grant.
All stock-based compensation expense is reported in the Statements
of Operations and Comprehensive (Loss) Income within "research and
development" expense or "general and administrative" expense, based
upon the assigned department of the award recipient.
(viii) Net (Loss) Income per Share
Basic net (loss) income per share is calculated by dividing the net
(loss) income by the weighted-average number of shares of common
stock outstanding for the period, without consideration for
potential dilutive shares of common stock. Diluted net (loss)
income per share is computed by dividing the net (loss) income by
the weighted-average number of common stock equivalents outstanding
for the period determined using the "treasury-stock method" and
"if-converted method" as applicable.
The Company’s "participating securities" include unvested common
stock awards issued upon early exercise of certain stock options,
as early exercised unvested common stock awards have a
non-forfeitable right to dividends. The Company’s participating
securities do not have a contractual obligation to share in the
Company’s losses, so in periods of net losses, the "two-class
method" of calculating basic and diluted earnings per share is not
required. In periods of net income, basic and diluted net loss per
share attributable to common stockholders is presented in
conformity with the two-class method required for participating
securities. Also, net income is attributed to both common
stockholders and participating security holders, and therefore, net
income is allocated to shares of common stock and participating
securities, as if all of the earnings for the period had been
distributed. Diluted earnings per share under the two-class method
is calculated using the more dilutive of the treasury stock or the
two-class method.
Due to a net loss for the three months ended March 31, 2022,
all otherwise potentially dilutive securities are antidilutive, and
accordingly, the reported basic net loss per share equals the
reported diluted net loss per share in this period.
(ix) Fair Value Measurements
Assets and liabilities recorded at fair value on a recurring basis
in the balance sheets are categorized based upon the level of
judgment associated with the inputs used to measure their fair
values. Fair value is defined as the exchange price that would be
received for an asset or an exit price that would be paid to
transfer a liability in the principal or most advantageous market
for the asset or liability in an orderly transaction between market
participants on the measurement date. Valuation techniques used to
measure fair value must maximize the use of observable inputs and
minimize the use of unobservable inputs. The authoritative guidance
on fair value measurements establishes a three-tier fair value
hierarchy for disclosure of fair value measurements as
follows:
•Level 1:
Quoted prices (unadjusted) in active markets for identical assets
or liabilities that are publicly accessible at the measurement
date.
•Level 2:
Observable prices that are based on inputs not quoted on active
markets, but that are corroborated by market data. These inputs may
include quoted prices for similar assets or liabilities or quoted
market prices in markets that are not active to the general
public.
•Level 3:
Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the assets
or liabilities.
The carrying amounts for financial instruments consisting of cash
and cash equivalents, accounts payable and accrued liabilities
approximate fair value due to their short maturities. The Company's
equity warrant holdings are carried at fair value based on
unobservable market inputs (see
Note 7).
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
Assets and liabilities are classified based on the lowest level of
input that is significant to the fair value measurements. The
Company reviews the fair value hierarchy classification on a
quarterly basis. Changes in the ability to observe valuation inputs
may result in a reclassification of levels for certain assets or
liabilities within the fair value hierarchy. The Company did not
have any transfers of assets and liabilities between the levels of
the fair value measurement hierarchy during the years
presented.
(x) Comprehensive (Loss) Income
Comprehensive (loss) income represents all changes in stockholders’
equity (deficit), except those resulting from distributions to
stockholders. For all periods presented in the accompanying
Condensed Financial Statements, comprehensive (loss) income was the
same as reported net (loss) income.
(xi) Recently Issued or Effective Accounting Standards
Recently issued or effective accounting pronouncements that impact,
or may have an impact, on the Company’s financial statements have
been discussed within the footnote to which each relates. Other
recent accounting pronouncements not disclosed in these Condensed
Financial Statements have been determined by the Company’s
management to have no impact, or an immaterial impact, on its
current and expected future financial position, results of
operations, or cash flows.
3. BALANCE SHEET ACCOUNT DETAIL
The composition of selected captions within the accompanying
Condensed Balance Sheets are summarized below:
(a) Property and Equipment, Net
“Property and equipment, net” consists of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
Furniture and fixtures |
$ |
596 |
|
|
$ |
596 |
|
Office equipment |
84 |
|
|
84 |
|
Laboratory equipment |
167 |
|
|
167 |
|
Leasehold improvements |
330 |
|
|
129 |
|
Property and equipment, at cost |
1,177 |
|
|
976 |
|
(Less): Accumulated depreciation and amortization |
262 |
|
|
221 |
|
Property and equipment, net |
$ |
915 |
|
|
$ |
755 |
|
Depreciation expense (included within “total operating expenses” in
the accompanying Condensed Statements of Operations and
Comprehensive (Loss) Income) for the three months ended March 31,
2022 and 2021 was $41 thousand and $64 thousand,
respectively.
(b) Other Assets
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
"Other assets" consists of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
Deposits |
$ |
71 |
|
|
$ |
71 |
|
Equity warrants (Note
7)
|
418 |
|
|
663 |
|
Other long term assets |
398 |
|
|
392 |
|
Other assets |
$ |
887 |
|
|
$ |
1,126 |
|
(c) Accounts Payable and Other Accrued
Liabilities
“Accounts payable and other accrued liabilities” consists of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
Trade accounts payable and other |
$ |
4,028 |
|
|
$ |
2,856 |
|
|
|
|
|
Operating lease liability, current |
635 |
|
|
609 |
|
Accrued clinical studies |
5,740 |
|
|
4,407 |
|
Contract liability |
174 |
|
|
697 |
|
Accrued interest, current |
148 |
|
|
— |
|
Income taxes payable |
55 |
|
|
55 |
|
Employee stock option pre-vesting exercise liability, current
portion |
25 |
|
|
56 |
|
Accounts payable and other accrued liabilities |
$ |
10,805 |
|
|
$ |
8,680 |
|
(d) Other Long-Term Liabilities
“Other long-term liabilities” consists of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
Operating lease liability, non-current |
$ |
425 |
|
|
$ |
585 |
|
Derivative liability |
71 |
|
|
114 |
|
|
|
|
|
Other long-term liabilities |
$ |
496 |
|
|
$ |
699 |
|
4. STOCKHOLDERS’ EQUITY AND EQUITY INCENTIVE PLANS
Common Stock Outstanding and Reserves for Future
Issuance
As of March 31, 2022 and December 31, 2021, the Company
had 20.7 million common shares issued and outstanding. Each share
of common stock is entitled to one vote.
The Company's outstanding equity awards and shares reserved for
future issuance under its 2020 and 2016 Equity Incentive Plans and
2020 Employee Stock Purchase Plan (the "ESPP") is summarized
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 |
|
December 31, 2021 |
Common stock awards reserved for future issuance under 2020 and
2016 Equity Incentive Plans |
8,954,066 |
|
|
9,266,200 |
|
Common stock awards reserved for future issuance under the 2020
Employee Stock Purchase Plan |
2,700,475 |
|
|
2,493,488 |
|
Stock options issued and outstanding under 2020 and 2016 Equity
Incentive Plans |
3,561,261 |
|
|
2,759,830 |
|
Restricted stock units outstanding under 2020 Equity Incentive
Plan |
351,422 |
|
|
17,251 |
|
Total shares of common stock reserved |
15,567,224 |
|
|
14,536,769 |
|
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
Equity Incentive Plans
The Company's Board of Directors and stockholders adopted and
approved the Company's 2020 Equity Incentive Plan (the “2020 Plan”)
on October 8, 2020. The 2020 Plan replaced the Company's 2016
Equity Incentive Plan that was adopted in December 2016 (the “2016
Plan”). However, awards outstanding under the 2016 Plan will
continue to be governed by its original terms. The number of shares
of the Company's common stock that were initially available for
issuance under the 2020 Plan equaled the initial sum of 9,000,000
shares
plus
2,432,980 shares that were then available for issuance under the
2016 Plan. The 2020 Plan provides for the following types of
awards: incentive and non-statutory stock options, stock
appreciation rights, restricted shares, and restricted stock
units.
The number of shares of common stock reserved for issuance under
the 2020 Plan are increased automatically on the first day of each
fiscal year, commencing in 2021 and through 2030, by a number equal
to the
lesser of:
(i) 4% of the shares of common stock outstanding on the last day of
the prior fiscal year; or (ii) the number of shares determined by
the Company's Board of Directors. In general, to the extent that
any awards under the 2020 or 2016 Plans are forfeited, terminate,
expire or lapse without the issuance of shares, or if the Company
reacquires the shares subject to awards granted under the 2020 or
2016 Plans, those shares will again become available for issuance
under the 2020 Plan, as will shares applied to pay the exercise or
purchase price of an award or to satisfy tax withholding
obligations related to any award.
Through March 31, 2022, all awards issued under the 2020 Plan
and 2016 Plan were in the form of stock options and restricted
stock units. These stock award agreements have service and/or
performance conditions for vesting, unless immediately vested on
the date of grant. Stock awards granted typically have
one to four-year service conditions for full vesting. Any
performance conditions for vesting are explicitly stated in each
award agreement and are associated with clinical, business
development, or operational milestones.
Stock options must be exercised, if at all, no later than 10 years
from the date of grant. Upon termination of employment, vested
stock options may be exercised within 12 months after the date of
termination upon death, six months after the date of termination
upon disability, and three months after the date of termination for
all other separations.
Pre-Vesting Exercise Feature of Certain Stock Options
The 2016 Plan permitted certain option holders to exercise awarded
options prior to vesting. Upon this early exercise, the options
became subject to a restricted stock agreement and remain subject
to the same vesting provisions in the corresponding stock option
award. These unvested options are subject to repurchase by the
Company upon employee termination at the same price exercised.
These unvested shares of common stock are reported as issued (but
not outstanding) on the accompanying Condensed Balance Sheets while
subject to repurchase by the Company. These shares are also
excluded from the basic net (loss) income per share until the
repurchase right lapses upon vesting, but are included in the
diluted net income per share for the three months ended
March 31, 2021.
The Company initially records a liability for these early exercises
that is subsequently reclassified into stockholders’ equity on a
pro rata basis as vesting occurs. As of March 31, 2022 and
December 31, 2021, the Company recorded the unvested portion
of the exercise proceeds of $25 thousand and $56 thousand,
respectively, within "accounts payable and other accrued
liabilities" in the accompanying Condensed Balance
Sheets.
Employee Stock Purchase Plan
As of March 31, 2022, a total of 2.7 million shares of
common stock are authorized and remain available for issuance under
the Company's ESPP. Beginning on January 1, 2021, and each January
1st thereafter, pursuant to the terms of the ESPP, the number of
common stock available for issuance under the ESPP is automatically
increased by an amount equal to the least of (i) one percent of the
total number of shares of common stock outstanding on the last day
of the previous fiscal year, (ii) 2.3 million shares, or (iii)
a number of shares determined by the board of
directors.
Under the terms of the ESPP, eligible employees can purchase common
stock through scheduled payroll deductions. The purchase price is
equal to the closing price of the Company's common stock on the
first or last day of the offering period (whichever is
less),
minus
a 15% discount.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
5. STOCK-BASED COMPENSATION
Stock-Based Compensation Summary
Stock-based compensation expense is recorded in the accompanying
Condensed Statements of Operations and Comprehensive (Loss) Income
based on the designated department of the recipient. Stock-based
compensation expense for the three months ended March 31, 2022 and
2021 was as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2022 |
|
2021 |
|
|
|
|
Research and development |
$ |
678 |
|
|
$ |
344 |
|
|
|
|
|
General and administrative |
1,996 |
|
|
1,019 |
|
|
|
|
|
Total stock-based compensation |
$ |
2,674 |
|
|
$ |
1,363 |
|
|
|
|
|
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
6. NET (LOSS) INCOME PER SHARE
The following
table sets forth the computation of basic and diluted net (loss)
income per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
|
|
2022 |
|
2021 |
Basic EPS |
|
|
|
|
|
|
|
Net (loss) income |
|
|
|
|
$ |
(20,238) |
|
|
$ |
10,376 |
|
Less: undistributed income allocated to participating
securities |
|
|
|
|
— |
|
|
90 |
|
Net (loss) income available to common shareholders |
|
|
|
|
$ |
(20,238) |
|
|
$ |
10,286 |
|
|
|
|
|
|
|
|
|
Basic weighted average shares outstanding |
|
|
|
|
20,710,224 |
|
|
20,336,022 |
|
Net (loss) per share—basic |
|
|
|
|
$ |
(0.98) |
|
|
$ |
(0.51) |
|
|
|
|
|
|
|
|
|
Diluted EPS |
|
|
|
|
|
|
|
Net (loss) income |
|
|
|
|
$ |
(20,238) |
|
|
$ |
10,376 |
|
Less: undistributed income reallocated to participating
securities |
|
|
|
|
— |
|
|
84 |
|
Net (loss) income available to common shareholders |
|
|
|
|
$ |
(20,238) |
|
|
$ |
10,292 |
|
|
|
|
|
|
|
|
|
Basic weighted average shares outstanding |
|
|
|
|
20,710,224 |
|
|
20,336,022 |
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
Common stock options |
|
|
|
|
— |
|
|
1,488,552 |
|
Diluted weighted average shares outstanding |
|
|
|
|
20,710,224 |
|
|
21,824,574 |
|
Net (loss) income per share—diluted |
|
|
|
|
$ |
(0.98) |
|
|
$ |
0.47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following outstanding potentially dilutive securities were
excluded from the calculation of diluted net loss per
share because their impact under the “treasury stock method” and
“if-converted method” would have been anti-dilutive for
the
periods presented:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2022 |
|
2021 |
|
|
|
|
Stock options, unexercised—vested and unvested |
3,561,261 |
|
|
632,781 |
|
|
|
|
|
Stock options early-exercised and unvested |
12,531 |
|
|
— |
|
|
|
|
|
Restricted stock units—unvested |
351,422 |
|
|
— |
|
|
|
|
|
Total |
3,925,214 |
|
|
632,781 |
|
|
|
|
|
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
7. FAIR VALUE MEASUREMENTS
The table below summarizes certain financial instruments measured
at fair value that are included within the accompanying balance
sheets, and their designation among the three fair value
measurement categories (see
Note 2(ix)):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
March 31, 2022 Fair Value Measurements |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
Money market funds |
$ |
175,010 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
175,010 |
|
Common stock in LianBio (included in "marketable
securities") |
291 |
|
|
— |
|
|
— |
|
|
291 |
|
Equity warrants in LianBio (included in "other assets") |
— |
|
|
— |
|
|
418 |
|
|
418 |
|
Total assets measured at fair value |
$ |
175,301 |
|
|
$ |
— |
|
|
$ |
418 |
|
|
$ |
175,719 |
|
|
|
|
|
|
|
|
|
|
December 31, 2021 Fair Value Measurements |
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
Money market funds |
$ |
171,332 |
|
|
— |
|
— |
|
$ |
171,332 |
|
Common stock in LianBio (included in "marketable
securities") |
483 |
|
|
— |
|
|
— |
|
|
$ |
483 |
|
Equity warrants in LianBio (included in "other assets") |
— |
|
|
— |
|
|
663 |
|
|
$ |
663 |
|
Total assets measured at fair value |
$ |
171,815 |
|
|
$ |
— |
|
|
$ |
663 |
|
|
$ |
172,478 |
|
Money Market Funds
Money market fund holdings are included in "cash and cash
equivalents" on the accompanying Condensed Balance Sheets and are
classified within
Level 1
of the fair value hierarchy because they have readily-available
market prices in active markets that are publicly observable at the
measurement date. These money market funds are invested in U.S.
Treasury bills and notes, and other obligations issued or
guaranteed as to principal and interest by the U.S. Government or
its agencies.
Equity Warrants
In March 2021, contemporaneous with the China Out-License
transaction (see
Note 9),
the Company and LianBio, executed a warrant agreement for the
Company to purchase, in three tranches, a stated number of common
stock in LianBio, a then privately-held pharmaceutical company
focused on China. The warrants vest upon the achievement of certain
clinical and regulatory events and have an exercise price at common
stock par value.
During the year ended December 31, 2021, one of these three
warrants vested and converted to 78,373 shares of LianBio common
stock ("equity securities") which were recorded within "marketable
securities" on the accompanying Balance Sheet as of December 31,
2021. The LianBio common stock is classified within
Level 1
of the fair value hierarchy because their value is based on the
closing common stock price of LianBio.
The remaining two unvested tranches of these warrants are
classified as
Level 3
in the fair value measurement hierarchy. The most significant
assumptions used in the option pricing valuation model to determine
the fair value as of March 31, 2022 included: LianBio common
stock volatility (based on the historical volatility of similar
companies), the probability of achievement of discrete clinical and
regulatory milestones for the remaining two unvested tranches of
these warrants, and application of an assumed discount rate for the
unvested warrants as of March 31, 2022.
These warrants allow for "noncash settlement" and therefore met the
criteria to be recognized as a "derivative asset" on the
accompanying Condensed Balance Sheets and are presented within
"other assets" as of March 31, 2022 (see
Note 3(b)).
They will be remeasured with a corresponding amount reported in
"other expense, net" on the accompanying statements of operations
and comprehensive (loss) income at each reporting date, until
exercised or expired.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
The following table sets forth a summary of the changes in fair
value of the equity warrants presented in "other assets" on the
accompanying Condensed Balance Sheets. The measurement of the
equity warrants represents a
Level 3
financial instrument:
|
|
|
|
|
|
|
Equity Warrants, presented on the Balance Sheets |
Fair value as of December 31, 2021 |
$ |
663 |
|
Revaluation of equity warrants included in "total revenues" within
the Condensed Statement of Operations for the three months ended
March 31, 2022 |
$ |
— |
|
Revaluation of equity warrants included in "other expense, net"
within the Condensed Statement of Operations for the three months
ended March 31, 2022 |
$ |
(245) |
|
Fair value as of March 31, 2022 |
$ |
418 |
|
|
|
|
|
|
|
|
Equity Warrants, presented on the Balance Sheets |
Fair value as of December 31, 2020 |
$ |
— |
|
Initial fair value estimate of equity warrants (included in "other
assets" within the Consolidated Balance Sheet) upon
issuance |
1,233 |
|
Fair value as of March 31, 2021 |
$ |
1,233 |
|
8. COMMITMENTS & CONTINGENCIES
(a) Facility Leases
Overview
In the ordinary course of business, the Company enters lease
agreements with unaffiliated third parties for facilities and
office equipment. As of March 31, 2022 and December 31,
2021, the Company had four active leases in Irvine, California for
adjacent office and laboratory suites.
In January 2021, the Company entered into a six-month lease for an
additional administrative office suite that was not capitalized due
to its under 12-month term. The company does not recognize lease
asset and liabilities for leases with a term of 12 months or less.
On July 30, 2021, the Company executed an amendment to extend the
term of this lease and lease an additional office suite, both
expiring January 31, 2024. This amendment was accounted for as a
"lease modification" and resulted in the recognition of an
"operating lease right-of-use asset" valued at $0.7 million as
of the execution date. The Company's two other capitalized facility
leases commenced on June 1, 2020 and also expire on
January 31, 2024. One includes a renewal option that was not
reasonably certain to be exercised at the time of lease
commencement.
The Company's operating leases have annual rent that is payable
monthly and carry fixed annual increases. Under these arrangements,
real estate taxes, certain operating expenses, and common area
maintenance are paid by the Company. Since these costs are variable
in nature, they are excluded from the measurement of the reported
right-of-use asset and liability and are expensed as incurred.
During the year ended December 31, 2021 and for the three months
ended March 31, 2022, the Company had no sublease arrangements with
it as lessor.
Financial Reporting Captions
The below table summarizes the lease asset and liability accounts
presented on the accompanying Condensed Balance
Sheets:
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Leases |
|
Consolidated Balance Sheet Caption |
|
March 31, 2022 |
|
December 31, 2021 |
Operating lease right-of-use assets - non-current |
|
Operating lease right-of-use assets |
|
$ |
926 |
|
|
$ |
1,074 |
|
|
|
|
|
|
|
|
Operating lease liability - current |
|
Accounts payable and other accrued
liabilities |
|
$ |
635 |
|
|
$ |
609 |
|
Operating lease liability - non-current |
|
Other long-term liabilities |
|
425 |
|
|
585 |
|
Total lease liabilities |
|
|
|
$ |
1,060 |
|
|
$ |
1,194 |
|
Components of Lease Expense
The liability associated with each lease is amortized over the
respective lease term using the “effective interest rate method.”
The Company’s right-of-use asset is amortized over the lease term
on a straight-line basis to lease expense, as reported on an
allocated basis within “research and development” and “general and
administrative” expenses in the accompanying Condensed Statements
of Operations and Comprehensive (Loss) Income. The Company combines
lease and non-lease components in the recognition of lease expense.
The components of lease cost were as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2022 |
|
2021 |
|
|
|
|
Operating lease cost |
$ |
143 |
|
|
$ |
60 |
|
|
|
|
|
Variable lease cost |
39 |
|
|
60 |
|
|
|
|
|
Short-term lease cost |
— |
|
|
32 |
|
|
|
|
|
Total lease cost |
$ |
182 |
|
|
$ |
152 |
|
|
|
|
|
Weighted-Average Remaining Lease Term and Applied Discount
Rate
As of March 31, 2022, the Company's facility leases had a
weighted average remaining lease term of 1 year, 10 months. The
weighted-average estimated incremental borrowing rate of 10% was
utilized to present value future minimum lease payments since an
implicit interest rate was not readily determinable.
Future Contractual Lease Payments
The below table summarizes the (i) minimum lease payments over
the next five years and thereafter, (ii) lease arrangement
imputed interest, and (iii) present value of future lease
payments:
|
|
|
|
|
|
Operating Leases - Future Payments |
March 31, 2022 |
2022 (remaining nine months) |
$ |
349 |
|
2023 |
761 |
|
2024 |
65 |
|
2025 |
— |
|
2026 |
— |
|
Total future lease payments, undiscounted |
$ |
1,175 |
|
(Less): Imputed interest |
(115) |
|
Present value of operating lease payments |
$ |
1,060 |
|
(b) In-License Agreements for Lotilaner
January 2019 Agreement for Skin and Eye Disease or Conditions in
Humans
In January 2019, the Company entered into a license agreement with
Elanco Tiergesundheit AG (“Elanco”) for exclusive worldwide rights
to certain intellectual property for the development and
commercialization of lotilaner in the
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
treatment or cure of any eye or skin disease or condition in humans
(the "Eye and Derm Elanco Agreement"). The Company has sole
financial responsibility for related development, regulatory, and
commercialization activities.
The Company paid a $1.0 million upfront payment at execution of the
Eye and Derm Elanco Agreement in January 2019. In September 2020,
the Company made a required $1.0 million clinical milestone payment
associated with the first two U.S. pivotal trials for the treatment
of Demodex blepharitis. The Company paid an additional $2.0 million
for its second pivotal trial milestone in April 2021, which was
recorded in “research and development” expense in the accompanying
Statements of Operations and Comprehensive Loss for the three
months ended March 31, 2021.
The Company may make further cash payments to Elanco pursuant to
the Eye and Derm Elanco Agreement upon achievement of certain
clinical milestones in the treatment of human skin diseases using
lotilaner for an aggregate maximum of $3.0 million and various
commercial and sales threshold milestones for an aggregate maximum
of $79.0 million. In addition, the Company will be obligated to pay
tiered contractual royalties to Elanco in the mid to high single
digits of its net sales. If the Company receives certain types of
payments from its sublicensees, it will be obligated to pay Elanco
a variable percentage in the low to mid double-digits of such
proceeds, except for territories in which the Company achieved
applicable regulatory approval prior to sublicense
execution.
As part of the China Out-License discussed in
Note 9,
the Company made a contractual payment in the amount of $2.5
million to Elanco following the receipt of $25 million of initial
proceeds from LianBio during the second quarter of
2021.
September 2020 Agreement for All Other Diseases or Conditions in
Humans
In September 2020, the Company executed an expanded in-license
agreement with Elanco, granting the Company a worldwide license to
certain intellectual property for the development and
commercialization of lotilaner for the treatment, palliation,
prevention, or cure of "all other" diseases and conditions in
humans (i.e., beyond that of the eye or skin) (the “All Human Uses
Elanco Agreement”). The Company issued Elanco 222,460 shares of its
common stock at the execution of the All Human Uses Elanco
Agreement. The fair value of these shares was $3.1 million
($14.0003 per share, approximating the issuance price of the
Company's Series C preferred stock in September 2020).
The Company is required to make further cash payments to Elanco
under the All Human Uses Elanco Agreement upon the achievement of
various clinical milestones for an aggregate maximum of $4.5
million and various commercial and sales threshold milestones for
an aggregate maximum of $77.0 million. In addition, the Company
will be obligated to pay contractual royalties to Elanco in the
single digits of its net product sales. If the Company receives
certain types of payments from its sublicensees, it will also be
obligated to pay Elanco a variable percentage in the low to mid
double-digits of such proceeds, except for territories in which the
Company achieved applicable regulatory approval prior to sublicense
execution.
In March 2021, the Company entered into the China Out-License
agreement with LianBio (see
Note 9),
which obligated it to grant Elanco an additional fixed 187,500
shares of the Company's common stock that were otherwise required
to be granted no later than the 18-month anniversary of the All
Human Uses Elanco Agreement for the Company's continued license
exclusivity. These additional shares were valued at $5.5 million
based on the Company's stock closing price of $29.30 per share (on
the date the issuance became contractually required) and were
reported within "research and development" expense within the
accompanying Condensed Statements of Operations and Comprehensive
(Loss) Income for the three months ended March 31,
2021.
(c) Employment Agreements
The Company has entered into employment agreements with eight of
its executive officers. These agreements provide for the payment of
certain benefits upon separation of employment under specified
circumstances, such as termination without cause, or termination in
connection with a change in control event.
(d) Litigation Contingencies
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
From time to time, the Company may be subject to various litigation
and related matters arising in the ordinary course of business. The
Company is currently not aware of any such matters where there is
at least a reasonable probability that a material loss, if any, has
been or will be incurred for financial statement
recognition.
(e) Indemnities and Guarantees
The Company has certain indemnity commitments, under which it may
be required to make payments to its officers and directors in
relation to certain transactions to the maximum extent permitted
under applicable laws. The duration of these indemnities vary, and
in certain cases, are indefinite and do not provide for any
limitation of maximum payments. The Company has not been obligated
to make any such payments to date and no liabilities have been
recorded for this contingency in the accompanying Condensed Balance
Sheets.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
9. OUT-LICENSE AGREEMENT
Out-License of TP-03 Commercial Rights in Greater China in March
2021
On March 26, 2021, the Company entered into an out-license
agreement with LianBio for its exclusive development and
commercialization rights of TP-03 (lotilaner ophthalmic solution,
0.25%) in the People’s Republic of China, Hong Kong, Macau, and
Taiwan (the “China Territory”) for the treatment of Demodex
blepharitis and Meibomian Gland Disease (the “China Out-License”).
LianBio is contractually responsible for all clinical development
and commercialization activities and costs within the China
Territory.
To date the Company received payments from LianBio totaling
$55.0 million related to initial consideration of
$25.0 million and two clinical development milestone
achievements of $30.0 million. During the three months ended
March 31, 2022 the Company did not receive any cash proceeds in
connection with the China Out-License.
The Company is also eligible to receive other payments and
consideration from LianBio upon achievement of certain additional
milestones, including: (i) TP-03 clinical development and
regulatory milestones of up to $45.0 million, (ii) an expected
drug supply agreement milestone of $5.0 million, (iii) TP-03
sales-based milestones for the China Territory of up to
$100 million, (iv) tiered mid-to-high-teen royalties for China
Territory TP-03 product sales, and (v) LianBio equity warrants,
which are subject to three TP-03 clinical/regulatory achievements
for complete vesting, of which one tranche vested in June
2021.
The Company recognized no "license fees" and $0.5 million
"collaboration revenue" for the three months ended March 31, 2022
in the accompanying Condensed Statements of Operations and
Comprehensive (Loss) Income, in accordance with the revenue
recognition accounting policy described in
Note 2(vii).
These amounts represent an allocation of the transaction price
based upon the partial satisfaction of the performance obligations
in the China Out-License.
These revenue amounts are each recognized upon satisfaction of the
following performance obligations (i) the transfer of TP-03 license
rights in the China Territory to LianBio and (ii) the actual or
partial completion of clinical activities and related data for the
Company's pivotal trials of TP-03 in the treatment of Demodex
blepharitis. As part of this revenue recognition model, the Company
was required to value the LianBio equity warrants, applying a
discounted cash flow model with highly subjective inputs for this
then private, pre-revenue company, and also considered the
probability of achievement of requisite vesting events. Subsequent
adjustments to the estimated initial fair value of these warrants
are reported within "total revenues" and "other (expense) income"
on the accompanying Condensed Statements of Operations for the
three months ended March 31, 2022. The first tranche of these
warrants vested and were exercised to LianBio common shares and are
reported within "marketable securities" on the accompanying
Condensed Balance Sheets as of December 31, 2021 and
March 31, 2022 (See
Note 7).
In future periods, the Company may recognize additional revenue
from contractual receipts due from LianBio as (1) performance
obligations are satisfied related to the completion of the TP-03
pivotal trial and as associated clinical data and reports are
delivered, (2) regulatory approval events are achieved, and (3)
LianBio records product sales of TP-03 in the China
Territory.
10. CREDIT FACILITY AGREEMENT
On February 2, 2022, the Company executed the Credit Facility with
Hercules and SVB with a term to February 2, 2027. The Credit
Facility provides an aggregate principal amount of up to
$175.0 million with tranched availability as follows:
$40.0 million at closing (with $20.0 million drawn in
February 2022), $25.0 million upon submission of a New Drug
Application ("NDA") with the FDA for TP-03, $35.0 million upon
FDA approval of TP-03, and $75.0 million upon achievement of
certain revenue thresholds and other conditions.
Each of the tranches may be drawn down in $5.0 million
increments at the Company's election. The Credit Facility includes
a four-year interest only period and is extendable to five years
upon meeting certain conditions.
The Credit Facility requires interest-only payments from the
issuance date through the amortization date of February 1, 2026,
followed by 12 months of principal amortization, unless extended
for one year to maturity upon meeting certain contractual
conditions. All unpaid amounts under the Credit Facility become due
on February 2, 2027.
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
Principal draws accrue interest on the outstanding principal
balance at a floating interest rate per annum equal to the
greater of
either (i) The Wall Street Journal prime rate
plus
5.20% or (ii) 8.45%. At execution of the Credit Facility, the
interest rate was 8.45%. On March 17, 2022 this prime rate
increased to 3.50% and the Credit Facility interest rate increased
to 8.70%. The Credit Facility interest rate further increased to
9.20% on May 5, 2022 based on the updated Wall Street Journal prime
rate.
The Company is required to pay a fee upon the earlier of (i) the
maturity date or (ii) the date the Company prepays, in full or in
part, the outstanding principal balance of the Credit Facility
("End of Term Charge"). The current End of Term Charge of $1.0
million was derived at the execution of the Credit Facility
by
multiplying
4.75% to the $20.0 million drawn at closing and is accreted to
"accrued interest" through the maturity date of the Credit
Facility.
As of March 31, 2022, the carrying value of this debt
consisted of $20.0 million principal outstanding
less
debt
issuance costs of approximately $0.9 million. These incurred legal
and administrative fees were recorded as a "contra-liability" and
accreted to interest expense using the "effective interest method"
over the loan term.
The calculated effective interest rate for this Credit Facility was
9.66% for the three months ended March 31, 2022. As of
December 31, 2021 the Company had no outstanding
debt.
During the three months ended March 31, 2022, the Company
recognized "interest expense" on its Condensed Statement of
Operations and Comprehensive (Loss) Income in connection with the
Credit Facility as follows:
|
|
|
|
|
|
|
March 31, 2022 |
Interest expense for term loan |
$ |
274 |
|
Accretion of End of Term Charge |
32 |
|
Amortization of debt issuance costs |
23 |
|
Total interest expense related to term loan |
$ |
329 |
|
The principal balance of this term loan and related accretion and
amortization as of March 31, 2022, were as
follows:
|
|
|
|
|
|
|
March 31, 2022 |
Term loan, gross (amount drawn) |
$ |
20,000 |
|
Debt issuance costs (legal and other administrative
fees) |
(875) |
|
Accretion of End of Term Charge |
32 |
|
Accumulated amortization of debt issuance costs |
23 |
|
Term loan, net |
$ |
19,180 |
|
TARSUS PHARMACEUTICALS, INC.
NOTES TO THE FINANCIAL STATEMENTS
(all tabular amounts presented in thousands, except share, per
share, per unit, and number of years)
(Unaudited)
11. SUBSEQUENT EVENT
May 2022 Follow-on Equity Raise
On May 5, 2022, the Company completed a follow-on public offering,
pursuant to the Company's effective Form S-3 shelf registration
statement, through an underwritten sale of 5,600,000 shares of its
common stock at a price of $13.50 per share. This resulted in gross
proceeds of $75.6 million before underwriting discounts,
commissions, and estimated expenses, for
net proceeds of approximately $70.6 million.
The Company also granted the underwriters a 30-day option to
purchase up to 840,000 additional shares of common stock at the
public offering price, less discounts, commissions, and estimated
expenses.
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking
statements. All statements other than statements of historical
facts contained in this report, including statements regarding our
future results of operations and financial position, future
revenue, business strategy, product candidates, planned preclinical
studies and clinical trials, results of clinical trials, research
and development costs, regulatory approvals, timing and likelihood
of success, as well as plans and objectives of management for
future operations, are forward-looking statements. These statements
involve known and unknown risks, uncertainties and other important
factors that are in some cases beyond our control and may cause our
actual results, performance or achievements to be materially
different from any future results, performance or achievements
expressed or implied by the forward-looking
statements.
The words “anticipate,” “believe,” contemplate,” “continue,”
“could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,” or
“would,” or the negative of these terms or other similar
expressions are intended to identify forward-looking statements.
Factors that may cause actual results to differ from expected
results, include, among others:
•the
likelihood of our clinical trials demonstrating safety and efficacy
of our product candidates, and other positive results;
•the
timing and progress of our current clinical trials and timing of
initiation of our future clinical trials, and the reporting of data
from our current and future trials;
•our
plans relating to the clinical development of our current and
future product candidates, including the size, number and disease
areas to be evaluated;
•the
prevalence of Demodex blepharitis and the size of the market
opportunity for our product candidates;
•the
rate and degree of market acceptance and clinical utility of our
product candidates;
•our
plans relating to commercializing our product candidates, if
approved, including sales strategy;
•the
impact of COVID-19 on our business and operations;
•the
success of competing therapies that are or may become
available;
•our
estimates of the number of patients in the United States ("U.S.")
or globally, as applicable, who suffer from Demodex blepharitis,
Meibomian Gland Disease ("MGD"), rosacea, Lyme disease and malaria
and the number of patients that will enroll in our clinical
trials;
•the
beneficial characteristics, safety, efficacy, therapeutic effects
and potential advantages of our product candidates;
•the
timing or likelihood of regulatory filings and approval for our
product candidates;
•our
ability to obtain and maintain regulatory approval of our product
candidates and our product candidates to meet existing or future
regulatory standards;
•our
plans relating to the further development and manufacturing of our
product candidates, including additional indications for which we
may pursue;
•our
ability to identify additional products, product candidates or
technologies with significant commercial potential that are
consistent with our commercial objectives;
•the
expected potential benefits of strategic collaborations with third
parties (including, for example, the receipt of payments,
achievement and timing of milestones under license agreements, and
the ability of our third party collaborators to commercialize our
product candidates in the territories under license) and our
ability to attract collaborators with development, regulatory and
commercialization expertise;
•existing
regulations and regulatory developments in the U.S. and other
jurisdictions;
•our
plans and ability to obtain or protect intellectual property
rights, including extensions of existing patent terms where
available;
•our
continued reliance on third parties to conduct additional clinical
trials of our product candidates, and for the manufacture of our
product candidates for preclinical studies and clinical
trials;
•the
need to hire additional personnel, in particular sales personnel,
and our ability to attract and retain such personnel;
•the
accuracy of our estimates regarding expenses, future revenue,
capital requirements and needs for additional
financing;
•our
financial performance;
•the
sufficiency of our existing capital resources to fund our future
operating expenses and capital expenditure
requirements;
•our
competitive position;
•our
expectations regarding the period during which we will qualify as
an emerging growth company under the JOBS Act; and
•our
anticipated use of our existing resources and the proceeds from our
Initial Public Offering ("IPO") and Follow-on Public Offering
(defined below).
We have based these forward-looking statements largely on our
current expectations and projections about our business, the
industry in which we operate and financial trends that we believe
may affect our business, financial condition, results of operations
and growth prospects, and these forward-looking statements are not
guarantees of future performance or development. These
forward-looking statements are subject to a number of risks,
uncertainties and assumptions, including those described in the
section titled “Risk Factors” elsewhere in this report. Moreover,
we operate in a very competitive and rapidly changing environment.
New risks emerge from time to time. It is not possible for our
management to predict all risks, nor can we assess the impact of
all factors on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ
materially from those contained in any forward-looking statements
we may make. In light of these risks, uncertainties and
assumptions, the forward-looking events and circumstances discussed
in this report may not occur and actual results could differ
materially and adversely from those anticipated or implied in the
forward-looking statements.
You should not rely upon forward-looking statements as predictions
of future events. Although we believe that the expectations
reflected in the forward-looking statements are reasonable, we
cannot guarantee that the future results, advancements,
discoveries, levels of activity, performance or events and
circumstances reflected in the forward-looking statements will be
achieved or occur. Moreover, except as required by law, neither we
nor any other person assumes responsibility for the accuracy and
completeness of the forward-looking statements. We undertake no
obligation to update publicly any forward-looking statements for
any reason after the date of this report to conform these
statements to actual results or to changes in our
expectations.
You should read this report and the documents that we reference in
this report and have filed with the SEC as exhibits to this report
with the understanding that our actual future results, levels of
activity, performance and events and circumstances may be
materially different from what we expect.
Overview of our Business
We are a biopharmaceutical company focused on the development and
commercialization of therapeutics, starting with eye care. Our lead
product candidate, TP-03 (lotilaner ophthalmic solution, 0.25%), is
a novel investigational eye drop in Phase 3 to treat blepharitis
caused by the infestation of Demodex mites, which is referred to as
Demodex blepharitis. Blepharitis ("Blephar" is a reference to
eyelid and “itis” is a reference to inflammation) is an ophthalmic
lid margin disease characterized by inflammation of the eyelid
margin, redness and ocular irritation, including a specific type of
eyelash dandruff called collarettes, which are pathognomonic for
Demodex blepharitis. Poorly controlled and progressive blepharitis
can lead to corneal damage over time and, in extreme cases,
blindness. There are an estimated 25 million people in the
U.S. who suffer from Demodex blepharitis.
We designed TP-03 to target and eradicate the root cause of Demodex
blepharitis — Demodex mite infestation. The active pharmaceutical
ingredient ("API") of TP-03, lotilaner, paralyzes and eradicates
mites and other parasites through the inhibition of
parasite-specific gamma-aminobutyric acid-gated chloride
("GABA-Cl")
channels.
To date, we have completed four Phase 2 trials, one Phase 2b/3
Saturn-1 trial, and one Phase 3 Saturn-2 trial for TP-03 in Demodex
blepharitis. Each of these trials for TP-03 met their primary,
secondary and/or exploratory endpoints, with the drug well
tolerated. In May 2022, we announced positive topline results of
the Saturn-2 trial and will use the data from the Saturn-1 and
Saturn-2 trials to support our submission of a new drug application
("NDA") in the second half of 2022. We believe that TP-03 has the
potential to be the first therapeutic approved by the U.S. Food and
Drug Administration ("FDA") for the treatment of Demodex
blepharitis and become the standard of care.
We intend to further advance our pipeline with the lotilaner API to
address several diseases across therapeutic categories in human
medicine, including eye care, dermatology, and other diseases. We
are developing product candidates to address targeted diseases with
high unmet medical needs, which currently include TP-03 for the
potential treatment of MGD, TP-04 for the potential treatment of
rosacea, and TP-05 for potential Lyme disease prophylaxis and
community malaria reduction.
Recent Business and Clinical Highlights
TP-03 Demodex Blepharitis Pivotal Trials, Saturn-1 &
Saturn-2:
In May 2022, we announced positive topline results of the Saturn-2,
our second and final pivotal trial. Saturn-2 enrolled 412 adults
having more than 10 collarettes per lid and at least mild lid
erythema. All pre-specified primary and secondary endpoints were
met, TP-03 was well tolerated and complete resolution of Demodex
blepharitis was demonstrated in patients treated with TP-03
(lotilaner ophthalmic solution, 0.25%).
Primary Endpoint:
•56%
of patients on TP-03 achieved the primary endpoint of complete
collarette cure, defined as 0-2 collarettes per lid at day 43,
compared to 13% on vehicle (p<0.0001).
◦89%
of patients on TP-03 achieved a clinically meaningful collarette
cure, defined as 0-10 collarettes per lid at day 43 compared to 33%
of those on vehicle (p<0.0001).
Secondary Endpoints:
•52%
of patients on TP-03 achieved the secondary endpoint of mite
eradication defined as 0 mites per lash at day 43, compared to 14%
on vehicle (p<0.0001).
•31.1%
of patients on TP-03 compared to 9.0% of patients on vehicle
(p<0.0001) achieved the secondary endpoint of a complete lid
erythema cure at day 43.
•19.2%
of patients on TP-03 achieved the secondary endpoint of a complete
composite cure, based on achieving both collarette cure and
erythema cure, compared to 4.0% on vehicle (p<0.0001) at day
43.
Safety Profile:
•TP-03
was well tolerated with a safety profile similar to the vehicle
group.
◦91%
of TP-03 patients reported that the drop comfort was neutral to
very comfortable.
◦There
were no serious treatment-related adverse events nor any
treatment-related adverse events leading to treatment
discontinuation.
We expect to use the positive data from the Saturn-1 and Saturn-2
trials to support our submission of an NDA in the second half of
2022.
TP-05 Lyme disease Phase 1 Trial, Callisto:
We advanced our Phase 1 Callisto trial, evaluating TP-05, a novel,
oral, non-vaccine therapeutic, for the prevention of Lyme disease.
In June 2021, we initiated the Callisto trial, a single ascending
dose and multiple ascending dose trial to evaluate the safety,
tolerability and pharmacokinetics ("PK") of TP-05 in healthy
volunteers with data expected in the second half of 2022. There are
currently no FDA-approved pharmacological prophylactic options for
Lyme disease, which is the most common vector-borne disease in the
U.S., transmitted to humans via Borrelia burgdorferi bacterium
infection following the bite of a tick vector.
We believe TP-05 is currently the only non-vaccine, drug-based,
preventive therapeutic in development that targets the ticks, and
potentially prevents Lyme disease transmission. It is designed to
rapidly provide systemic blood levels of lotilaner potentially
sufficient to kill infected ticks attached to the human body before
they can transmit the Borrelia bacteria that causes Lyme
disease.
TP-03 China Territory Out-License:
In March 2021, we executed an out-license agreement (the "China
Out-License") with LianBio Ophthalmology Limited ("LianBio"),
granting exclusive commercial rights to TP-03 for the treatment of
Demodex blepharitis and MGD within The People’s Republic of China,
Macau, Hong Kong, and Taiwan (the "China Territory"). LianBio has
publicly communicated that they expect to initiate a TP-03 Phase 3
pivotal trial in China for the treatment of Demodex blepharitis in
the second half of 2022.
To date, we've received contractual cash proceeds from LianBio of
$55 million, representing initial consideration of
$25 million, and $30 million for the achievement of two
clinical development milestones. We also received equity warrant
rights in LianBio as part of this license that are subject to
clinical and regulatory vesting provisions.
We are further eligible to receive (i) Saturn-2 topline data
milestone of $15 million and a drug supply agreement execution
milestone of $5 million (we expect to receive both in 2022),
(ii) China-based clinical and regulatory milestones totaling
$30 million ($10 million of which we expect in the second half
of 2022 for the initiation of their Phase 3 pivotal trial in
China), and (iii) sales threshold milestones in the China Territory
totaling $100 million. We are also entitled to receive tiered
mid-to-high teen royalties on the net product sales of TP-03 within
the China Territory.
Credit Facility with Hercules Capital and Silicon Valley
Bank:
On February 2, 2022, we executed a loan and security agreement with
Hercules Capital and Silicon Valley Bank (the "Credit Facility).
This $175 million Credit Facility has tranched availability as
follows:
•$40
million at closing (with $20 million drawn in February 2022 and $20
million remaining available)
•$25
million upon NDA submission of TP-03
•$35
million upon FDA approval of TP-03
•$50
million upon achievement of certain quarterly revenue
thresholds
•$25
million available with lender approval
Capital draws are at our election and are in $5 million increments.
This Credit Facility includes a four-year interest only period and
is extendable to five years upon meeting certain conditions that we
expect to achieve.
Follow-on Public Offering:
On May 5, 2022, we completed a follow-on public offering, pursuant
to our effective Form S-3 shelf registration statement, through an
underwritten sale of 5.6 million shares of our common stock at a
price to the public of $13.50 per share. Gross proceeds were
$75.6 million before underwriting discounts, commissions, and
estimated expenses. We granted the underwriters a 30-day option to
purchase up to 840,000 additional shares of common stock at the
public offering price, less discounts, commissions, and estimated
expenses.
Corporate and Financial Overview
We were incorporated as a Delaware corporation in November 2016,
and our headquarters is located in Irvine, California. Since our
inception, we have devoted substantially all of our resources to
organizing and staffing our company, acquiring intellectual
property, clinical development of our product candidates, building
our research and development capabilities, raising capital, and
enhancing our corporate infrastructure.
To date we have financed our operations through private placements
of preferred stock, convertible promissory notes, the net proceeds
from issuance of common stock in our IPO and Follow-on Public
Offering, cash proceeds from our out-licensing arrangements, and
draw downs on our Credit Facility.
We have incurred significant net operating losses in every year
since our inception and expect to continue to incur significant
operating expenses and, other than the effect of license fee
revenue from the China Out-License Agreement, increasing operating
losses for the foreseeable future. Our net (loss) income was
$(20.2) million and $10.4 million for the three months ended March
31, 2022 and 2021, respectively. Our net losses and any net income
we may generate may fluctuate significantly from quarter to quarter
and year to year and could be substantial. As of March 31,
2022 and December 31, 2021, we had an accumulated deficit of
$66.9 million and $46.7 million, respectively, from our research
and development and general and administrative activities since our
inception. We anticipate that our operating expenses will increase
significantly as we:
•conduct
and complete clinical activities for our lead product candidate,
TP-03, for the treatment of Demodex blepharitis including our Phase
3 trial, Saturn-2;
•advance
the clinical development of TP-03 for the potential treatment of
MGD, TP-04 for the potential treatment of rosacea and TP-05 for
potential Lyme prophylaxis and community malaria
reduction;
•seek
regulatory and marketing approvals for product candidates that
successfully complete clinical development, if any;
•establish
our own sales force in the U.S. to commercialize our products for
which we obtain regulatory approval;
•engage
with contract manufacturers to ensure a sufficient supply chain
capacity to provide commercial quantities of any products for which
we may obtain marketing approval;
•maintain,
expand and protect our intellectual property
portfolio;
•hire
additional staff, including clinical, scientific, technical,
regulatory, marketing, operations, financial, and other support
personnel, to execute our business plan; and
•add
information systems and personnel to support our product
development and potential future commercialization efforts, and to
enable us to operate as a public company.
We do not have any products approved for sale and we have not yet
generated any revenue from product sales. However, we recognized
"license fees" and "collaboration revenue" from our China
Out-License for the three months ended March 31, 2022 and 2021 for
an aggregate $0.5 million and $33.4 million, respectively
(see
Note 9),
and expect to recognize additional revenue under these captions
from this arrangement in future periods.
We do not expect to generate revenues from product sales unless and
until we successfully complete clinical development and obtain
regulatory approval for a product candidate and commercially launch
such product. Until such time as we can generate significant
revenue from product sales, if ever, we expect to finance our
operations through private or public equity or debt financings, or
collaborations, strategic alliances, or licensing arrangements with
third parties. Adequate funding may not be available to us when
needed on acceptable terms, or at all. If we raise additional funds
through collaborations, strategic alliances, or licensing
arrangements with third parties, we may have to relinquish valuable
rights to our intellectual property, future revenue streams,
research programs or product candidates or grant licenses on terms
that may not be favorable to us. If we are unable to raise
additional capital or enter into such agreements as and when
needed, we could be forced to significantly delay, scale back, or
discontinue our product development and/or commercialization plans,
which would negatively and adversely affect our financial
condition.
Because of the numerous risks and uncertainties associated with
drug product development, we are unable to accurately forecast the
timing or amount of increased expenses or when or if we will be
able to achieve or maintain profitability. Even if we are able to
generate revenue from product sales, we may not become profitable.
If we fail to become profitable or are unable to sustain
profitability on a continuing basis, then we may be unable to
continue our operations at planned levels.
As of March 31, 2022, our aggregate cash, cash equivalents and
marketable securities was $175.3 million – see the section below
titled “Management's Discussion and Analysis of Financial Condition
and Results of Operations — Liquidity and Capital
Resources.”
Impact of the COVID-19 Pandemic on our Operations
Efforts to contain the spread of COVID-19 in the U.S. (including in
California where our corporate headquarters and laboratory facility
are located) and other countries have included quarantines,
shelter-in-place orders, and various other government restrictions
in order to control the spread of this virus.
We have been monitoring the COVID-19 pandemic as it continues to
progress and its potential impact on our business. We have taken
important steps to ensure the workplace safety of our employees
when working within our laboratory and administrative offices, or
when traveling to our clinical trial sites. We have also
implemented a vaccination policy and we may take further actions as
may be required by federal, state or local
authorities.
To date, we have been able to continue our key business activities
and advance our clinical programs. However, in the future, it is
possible that our clinical development timelines and business plans
could be adversely affected. We maintain regular communication with
our vendors and clinical sites to appropriately plan for, and
mitigate, the impact of the COVID-19 pandemic on our operations.
The ultimate effect from this pandemic on our development timelines
for TP-03 and our other product candidates is inherently
uncertain.
See the section titled
Risk Factors
in our Annual Report on Form 10-K for the year ended
December 31, 2021, filed with the SEC on March 14, 2022
and in this Quarterly Report, for a further discussion of the
potential adverse impact of COVID-19 on our business, results of
operations and financial condition.
Results of Operations
Comparison of the Three Months Ended March 31, 2022 and
2021
The following table summarizes our results of operations for the
periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
Change |
|
2022 |
|
2021 |
|
|
(in thousands) |
Revenues: |
|
|
|
|
|
License fees |
$ |
— |
|
|
$ |
33,311 |
|
|
$ |
(33,311) |
|
Collaboration revenue |
539 |
|
|
121 |
|
|
418 |
|
Total revenues |
539 |
|
|
33,432 |
|
|
(32,893) |
|
Operating expenses: |
|
|
|
|
|
Cost of license fees and collaboration revenue |
33 |
|
|
1,297 |
|
|
(1,264) |
|
Research and development |
12,081 |
|
|
16,261 |
|
|
(4,180) |
|
General and administrative |
7,946 |
|
|
5,160 |
|
|
2,786 |
|
Total operating expenses |
20,060 |
|
|
22,718 |
|
|
(2,658) |
|
(Loss) income from operations before other (expense) income and
income taxes |
(19,521) |
|
|
10,714 |
|
|
(30,235) |
|
Other (expense) income: |
|
|
|
|
|
Interest (expense) income, net |
(316) |
|
|
9 |
|
|
(325) |
|
Other income (expense), net |
37 |
|
|
(34) |
|
|
71 |
|
Unrealized loss on equity securities |
(192) |
|
|
— |
|
|
(192) |
|
Change in fair value of equity warrants |
(245) |
|
|
— |
|
|
(245) |
|
Total other expense, net |
(716) |
|
|
(25) |
|
|
(691) |
|
Benefit for income taxes |
(1) |
|
|
(313) |
|
|
312 |
|
Net (loss) income and comprehensive (loss) income |
$ |
(20,238) |
|
|
$ |
10,376 |
|
|
$ |
(30,614) |
|
License Fees and Collaboration Revenue
License fees and collaboration revenue was $0.5 million for the
three months ended March 31, 2022. This amount was attributable to
the contractual milestones under the China Out-License (see
Note 9)
that have been fully or partially completed by March 31, 2022.
These amounts represent the satisfaction of the transfer of TP-03
license rights to LianBio and the partial completion of
clinical-related "performance obligations".
We will recognize additional "license fee and collaboration
revenue" to the extent the contractual performance obligations are
further satisfied or other events occur, specifically related to
(i) milestone payments upon TP-03 pivotal trial completion and the
delivery of associated clinical data and reports to our licensee,
(ii) achievement of regulatory events that trigger milestone
payments, and (iii) our licensee's product sales of TP-03 in the
China Territory.
Cost of License Fees and Collaboration Revenue
Cost of license fees and collaboration revenue decreased by $1.3
million for the three months ended March 31, 2022, as compared
to the prior year period. These amounts relate to our contractual
payment obligations to our licensor that are attached to our China
Out-License proceeds.
Research and Development Expenses
Research and development expenses decreased by $4.2 million for the
three months ended March 31, 2022, as compared to the prior
year period. The decrease was primarily due to non-recurring costs
in the prior year period including (i) a contractual payment in
March 2021 in the form of 187,500 shares of our common stock then
valued at $5.5 million to extend the period of our September 2020
in-license agreement, and (ii) contractual payment of $2 million
under our January 2019 in-license for the commencement of our
Saturn-2 trial. These decreases were partially offset by (i)
increased clinical and preclinical study costs of $1.3 million,
(ii) increased manufacturing and formulation costs of
$0.6 million, and (iii) increased payroll and
personnel-related costs, including stock-based compensation, of
$1.1 million, for eight employee additions period over period
to drive our product development initiatives.
General and Administrative Expenses
General and administrative expenses increased by $2.8 million for
the three months ended March 31, 2022, as compared to the
prior year period. The increase was primarily due to (i) a $2.1
million increase in payroll and personnel-related costs, including
stock-based compensation, for 14 employee additions period over
period to support our business growth, and (ii) increased
commercial and market research costs of $0.6 million.
Other Expense, Net
Other expense, net increased by $0.7 million which primarily
consists of (i) interest expense of $0.3 million related to the
Credit Facility executed in February 2022, (ii) mark-to-market
decrease of $0.2 million for the LianBio equity warrants we
received as part of our China Out-License in March 2021, and (iii)
mark-to-market decrease of $0.2 million for revaluation of LianBio
common stock held (after our exercise of the first warrant
tranche).
Benefit for Income Taxes
We maintain a valuation allowance against our net deferred tax
assets as of March 31, 2022 and 2021 due to the uncertainty
that such assets will be realized. We evaluate the recoverability
of our deferred tax assets on at least an annual basis. For the
three months ended March 31, 2022, we recorded a nominal income tax
benefit of $1 thousand due to the losses we incurred in that
period.
Liquidity and Capital Resources
Sources of Liquidity
We will continue to be dependent upon equity, debt financing,
and/or other forms of capital raises at least until we are able to
generate significant ongoing positive cash flows to support our
operations. As of March 31, 2022, we had cash and cash
equivalents of $175.0 million and marketable securities of
$0.3 million.
Since our inception, our operations have been substantially
financed by cash proceeds of $61 million from private placements of
preferred stock, the proceeds from our IPO, China Out-License
consideration, a credit facility capital draw, and proceeds from
our Follow-on Public Offering (defined below). In connection with
our IPO, we sold 6,325,000 shares of our common stock (inclusive of
the full exercise of the underwriters’ option to purchase 825,000
shares of common stock). After deducting underwriting discounts,
commissions and other related expenses, our IPO proceeds were $91.7
million. In May 2022, we sold 5,600,000 shares of our common stock
at a price to the public of $13.50 per share (exclusive of up to
840,000 additional shares of common stock that the underwriters
have an option to purchase at the public offering price) (the
“Follow-on Public Offering). After deducting, discounts,
commissions, and other related expenses, the
net proceeds to us from the Follow-on Public Offering are expected
to be approximately $70.6 million.
To date, we have received $55 million of total proceeds in
connection with our China Out-License (see
Note 9).
We expect to receive an additional $30 million during 2022 for
the achievement of certain clinical development milestones
(inclusive of our Saturn-2 topline data milestone of $15 million
that was achieved in May 2022) for aggregate milestone receipts
through December 2022 of $85 million. The remaining $120
million of potential milestones under this out-license will be
received upon future clinical, regulatory and sales achievements
within the China Territory.
In February 2022, we drew $20 million from our credit facility with
Hercules Capital and Silicon Valley Bank. This $175 million
facility has tranched availability as follows:
•
$40 million at closing ($20 million drawn and $20 million
available)
•
$25 million upon NDA submission of TP-03
•
$35 million upon FDA approval of TP-03
•
$50 million upon achievement of certain quarterly revenue
thresholds
•
$25 million with lender approval
Capital draws are at our election and are in $5 million increments.
This credit facility includes a four-year interest only period and
is extendable to five years upon meeting certain conditions that we
expect to achieve. We currently have no other financing
commitments, such as lines of credit or guarantees.
Funding Requirements
Our operating expenditures currently consist of research and
development expenses (including activities within our preclinical,
clinical, regulatory, and drug manufacturing initiatives) and
general and administrative expenses. Our use of cash is impacted by
the timing and extent of payments for each of these activities and
other business requirements.
We believe that our cash, cash equivalents and marketable
securities of $175.3 million as of March 31, 2022 is
sufficient to fund our current and planned operations for at least
the next twelve months from the date of this filing on Form
10-Q.
We expect that this $175.3 million, in addition to (i) our May 2022
equity raise net proceeds of $70.6 million, (ii) our expected China
Out-License milestone cash proceeds of $30 million during 2022
(with a $15 million cash milestone expected by 2024), and (iii) $80
million of expected availability through 2023 from our Credit
Facility (excluding the $20 million draw in February 2022) subject
to the achievement of certain regulatory milestones should provide
sufficient capital resources to fund our planned corporate
expenses, research and development expenses, and capital
expenditure requirements at least into 2026.
We base this current cash runway estimate on our revenue and
expense assumptions that may require future adjustments as part of
our ongoing business decisions within pipeline development and our
other corporate initiatives. Accordingly, we may require additional
capital resources earlier than we currently expect.
On November 1, 2021, we filed a shelf registration statement (the
“Shelf Registration Statement”) on Form S-3 with the SEC (that was
declared effective by the SEC on November 5, 2021), which permits
us to offer up to $300.0 million of common stock, preferred stock,
debt securities and warrants in one or more offerings and in any
combination, including in units from time to time. Our Shelf
Registration Statement is intended to provide us with additional
flexibility to access capital markets for general corporate
purposes, which may include working capital, capital expenditures,
other corporate expenses and acquisitions of complementary
products, technologies, or businesses. As part of this Shelf
Registration Statement, we also filed a sales agreement prospectus
covering the sale of up to $100 million of our common stock
pursuant to an Open Market Sale AgreementTM
(the “Sale Agreement”) with Jefferies LLC. Through the date of this
filing, we have not sold any shares of our common stock in at the
market transactions pursuant to the Sale Agreement. We conducted
the Follow-on Public Offering pursuant to this Shelf Registration
Statement.
To date, we have not generated any product sales. We do not expect
to report any product revenue unless and until we (1) complete
development of any of our product candidates; (2) obtain
applicable regulatory approvals; and then (3) successfully
commercialize or enter into other collaborative agreements for our
product candidates with third parties. We do not know with
certainty when, or if, any of these items will ultimately
occur.
We expect to incur significant operating losses for the foreseeable
future, and expect these losses to further increase, as we ramp up
our clinical development programs and begin activities for
commercial launch readiness. We may also encounter unforeseen
expenses, difficulties, complications, delays and other currently
unknown factors that could adversely affect our
business.
We may require additional capital to fully develop our product
candidates and to execute our business strategy. Our requirements
of a future capital raise will depend on many factors,
including:
•the
scope, timing, rate of progress and costs of our drug discovery
efforts, preclinical development activities, laboratory testing and
clinical trials for our product candidates;
•the
number and scope of clinical programs we decide to
pursue;
•the
cost, timing and outcome of preparing for and undergoing regulatory
review of our product candidates;
•the
scope and costs of development and commercial manufacturing
activities;
•the
cost and timing associated with commercializing our product
candidates, if they receive marketing approval;
•the
amount of revenue, if any, received from commercial sales of our
product candidates, should any of our product candidates receive
marketing approval;
•the
achievement of milestones or occurrence of other developments that
trigger payments under any collaboration agreements we might have
at such time and availability under our Credit
Facility;
•the
extent to which we acquire or in-license other product candidates
and technologies;
•the
costs of preparing, filing and prosecuting patent applications,
maintaining and enforcing our intellectual property rights and
defending intellectual property-related claims;
•our
ability to establish and maintain collaborations on favorable
terms, if at all;
•our
efforts to enhance operational systems and our ability to attract,
hire and retain qualified personnel, including personnel to support
the development of our product candidates and, ultimately, the sale
of our products, following FDA approval;
•our
implementation of various computerized information
systems;
•impact
of COVID-19 on our clinical development or operations;
and
•the
costs associated with being a public company.
A change in the outcome of any of these or other variables with
respect to the development of any of our product candidates could
significantly change the costs and timing associated with the
development of that product candidate. Furthermore, our operating
plans may change in the future, and we will continue to require
additional capital to meet operational needs and capital
requirements associated with such operating plans. If we raise
additional funds by issuing equity securities, our stockholders may
experience dilution. Any future debt financing into which we enter
may impose upon us additional covenants that restrict our
operations, including limitations on our ability to incur liens or
additional debt, pay dividends, repurchase our common stock, make
certain investments or engage in certain merger, consolidation or
asset sale transactions. Any debt financing or additional equity
that we raise may contain terms that are not favorable to us or our
stockholders.
Adequate funding may not be available to us on acceptable terms or
at all. Our potential inability to raise capital when needed could
have a negative impact on our financial condition and our ability
to pursue our business strategies. If we are unable to raise
additional funds as required, we may need to delay, reduce, or
terminate some or all development programs and clinical trials. We
may also be required to sell or license our rights to product
candidates in certain territories or indications that we would
otherwise prefer to develop and commercialize ourselves. If we are
required to enter into collaborations and other arrangements to
address our liquidity needs, we may have to give up certain rights
that limit our ability to develop and commercialize our product
candidates or may have other terms that are not favorable to us or
our stockholders, which could materially and adversely affect our
business and financial prospects. See the section titled “Risk
Factors” in this report for additional risks associated with our
substantial capital requirements.
Summary Statement of Cash Flows
The following table sets forth the primary sources and uses of
cash, cash equivalents and restricted cash for each of the periods
presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31, |
|
2022 |
|
2021 |
|
(in thousands) |
Net cash provided by (used in) : |
|
|
|
Operating activities |
$ |
(15,286) |
|
|
$ |
(11,794) |
|
Investing activities |
(161) |
|
|
(175) |
|
Financing activities |
19,125 |
|
|
19 |
|
Net increase in cash, cash equivalents and restricted
cash |
$ |
3,678 |
|
|
$ |
(11,950) |
|
Net Cash Provided by (Used in) Operating Activities
Net cash used in operating activities was $15.3 million for the
three months ended March 31, 2022. Though we recognized $0.5
million of license fee and collaboration revenue, no corresponding
cash was received in the current three-month period in connection
with our China Out-License. In the current three-month period, our
cash payments to vendors for our operating activities totaled $10.1
million and payroll-related cash payments (inclusive of 2021 bonus
payouts) totaled $5.2 million.
Net cash used in operating activities was $11.8 million for the
three months ended March 31, 2021. Though we recognized $33.4
million of license fee and collaboration revenue from the China
Out-License in the prior year period, no corresponding cash was
received until the second quarter of 2021. Our cash payments to
vendors for our operating activities totaled $9.2 million and
payroll-related cash payments (inclusive of 2020 bonus payouts)
totaled $2.7 million.
Net Cash Used in Investing Activities
Net cash used in investing activities was $0.2 million for the
three months ended March 31, 2022, which consisted of leasehold
improvements for our laboratory and administrative offices and
various purchases of computer hardware and office
equipment.
Net cash used in investing activities was $0.2 million
for
the three months ended March 31, 2021, which consisted of
purchases of property and equipment and leasehold improvements for
our laboratory and administrative offices.
Net Cash Provided by Financing Activities
Net cash provided by financing activities was $19.1 million for the
three months ended March 31, 2022, which was attributable to
proceeds from the Credit Facility.
Net cash provided by financing activities was $19 thousand for the
three months ended March 31, 2021, and was attributable to
proceeds from the exercise of stock options.
Critical Accounting Policies, Significant Judgments and Use of
Estimates
The preparation of our Condensed Financial Statements in conformity
with GAAP requires management to make estimates and assumptions
that affect the amounts reported in the financial statements and
notes to the financial statements. Some of those judgments can be
subjective and complex, and therefore, actual results could differ
materially from those estimates are different assumptions and
conditions. A summary of our critical accounting policies is
presented in our filed Annual Report on Form 10-K for the year
ended December 31, 2021.
There were no material changes to our previously reported "Critical
Accounting Policies" during the three months ended March 31,
2022.
Recent Accounting Pronouncements
A description of recent accounting pronouncements that may
potentially impact our financial position, results of operations or
cash flows are disclosed in the footnote to which each relates
within these accompanying Condensed Financial
Statements.
Off-Balance Sheet Arrangements
Since our inception, we have not engaged in any off-balance sheet
arrangements, as defined in the rules and regulations of the
SEC.
Indemnification Agreements
As permitted under Delaware law and in accordance with our bylaws,
we indemnify our officers and directors for certain events or
occurrences while the officer or director is or was serving in such
capacity. We are also party to indemnification agreements with our
officers and directors. We believe the fair value of the
indemnification rights and agreements is minimal. Accordingly, we
have not recorded any liabilities for these indemnification rights
and agreements as of March 31, 2022.
JOBS Act Accounting Election
The Jumpstart Our Business Startups Act of 2012 (the "JOBS Act")
permits an “emerging growth company” such as us to take advantage
of an extended transition period to comply with new or revised
accounting standards applicable to public companies. We have
irrevocably elected to opt out of this provision and, as a result,
we will comply with new or revised accounting standards as required
when they are adopted.
We will remain an emerging growth company until the
earliest of
(1) the last day of our first fiscal year (a) following
the fifth anniversary of the completion of our IPO, (b) in
which we have total annual gross revenues of at least
$1.07 billion or (c) in which we are deemed to be a large
accelerated filer, which means the market value of our common stock
that is held by non-affiliates exceeds $700 million of the
prior June 30th and (2) the date on which we have issued more
than $1.0 billion in non-convertible debt securities during
the prior three-year period.
Item 3. Quantitative and Qualitative Disclosures about Market
Risk
Interest Rate Risk
The market risk inherent in our financial instruments and in our
financial position represents the potential loss arising from
adverse changes in interest rates. As of March 31, 2022, we
had cash and cash equivalents of $175.0 million, consisting of
interest-bearing money market accounts, for which the fair market
value would be affected by changes in the general level of United
States interest rates. However, due to the short-term maturities
and the low-risk profile of our investments, an immediate 100 basis
point change in interest rates would not have a material effect on
the fair market value of our cash and cash equivalents. As of
March 31, 2022, we had $19.2 million in variable rate debt
outstanding. Our Credit Facility bears interest at an annual rate
equal to the
greater of
(i) the Wall Street Journal prime rate
plus
5.20% or (ii) 8.45%. A hypothetical change in interest rate of 10%
would have resulted in a nominal change in interest expense for the
three months ended March 31, 2022.
We do not believe that inflation, interest rate changes, or foreign
currency exchange rate fluctuations had a significant impact on our
results of operations for any periods presented
herein.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive
Officer and our Chief Financial Officer, has evaluated the
effectiveness of our disclosure controls and procedures (as defined
in Rules 13a-15(e) and 15d-15(e) under the Exchange Act of 1934, as
amended ("Exchange Act")) as of the end of the period covered by
this report. Based upon that evaluation, our Chief Executive
Officer and Chief Financial Officer concluded that, as of the end
of the period covered by this report, our disclosure controls and
procedures were effective to provide reasonable assurance that
information required to be disclosed by us in the reports that we
file or submit under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the
SEC’s rules and forms and to provide reasonable assurance that such
information is accumulated and communicated to our management,
including our Chief Executive Officer and Chief Financial Officer,
as appropriate, to allow timely decisions regarding required
disclosure.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial
reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the
Exchange Act) that occurred during the period covered by this
report that has materially affected, or is reasonably likely to
materially affect, our internal control over financial
reporting.
Inherent Limitations on Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief
Financial Officer, do not expect that our disclosure controls or
our internal controls over financial reporting will prevent all
errors and all fraud. A control system, no matter how well
conceived and operated, can provide only reasonable, not absolute,
assurance that the objectives of the control system are met.
Further, the design of a control system must reflect the fact that
there are resource constraints, and the benefits of controls must
be considered relative to their costs. Because of the inherent
limitations in all control systems, no evaluation of controls can
provide absolute assurance that all control issues and instances of
fraud, if any, have been detected. These inherent limitations
include the realities that judgments in decision-making can be
faulty, and that breakdowns can occur because of a simple error or
mistake. Additionally, controls can be circumvented by the
individual acts of some persons, by collusion of two or more people
or by management override of the controls. The design of any system
of controls is also based in part upon certain assumptions about
the likelihood of future events, and there can be no assurance that
any design will succeed in achieving its stated goals under all
potential future conditions, over time, controls may become
inadequate because of changes in conditions, or the degree of
compliance with policies or procedures may deteriorate. Because of
the inherent limitations in a cost-effective control system,
misstatements due to error or fraud may occur and not be
detected.
PART II—OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently a party to any material legal proceedings.
From time to time, we may become involved in legal proceedings
arising in the ordinary course of our business. Regardless of
outcome, litigation can have an adverse impact on us due to defense
and settlement costs, diversion of management resources, negative
publicity, reputational harm and other factors.
Item 1A. Risk Factors
As of the date of this filing, there have been no material changes
to the risk factors included in our Annual Report on Form 10-K for
the year ended December 31, 2021, as filed with the SEC on
March 14, 2022, other than the below.
Risks Related to Development and Commercialization of Our Product
Candidates
Clinical drug development is a lengthy, expensive and risky process
with uncertain timelines and uncertain outcomes, and results of
earlier studies and trials may not be predictive of future results.
If clinical trials of our product candidates, particularly TP-03
for the treatment of Demodex blepharitis, do not meet safety or
efficacy endpoints or are prolonged or delayed, we may be unable to
obtain required regulatory approvals, and therefore be unable to
commercialize our product candidates on a timely basis or at
all.
Before obtaining marketing approval from regulatory authorities for
the sale of our product candidates, we must conduct extensive
clinical trials to demonstrate the safety and efficacy of the
product candidates in humans. The research and development of drugs
is an extremely risky industry. Only a small percentage of product
candidates that enter the development process ever receive
marketing approval. Failure or delay can occur at any time during
the clinical trial process. To date, we have focused substantially
all of our efforts and financial resources on identifying,
acquiring, and developing our product candidates, including
conducting preclinical studies and clinical trials. Clinical
testing is expensive and can take many years to complete, and we
cannot be certain that any clinical trials will be conducted as
planned or completed on schedule, if at all. Furthermore, product
candidates are subject to continued preclinical safety studies,
which may be conducted concurrently with our clinical testing. The
outcomes of these safety studies may delay the launch of or
enrollment in future clinical trials and could impact our ability
to continue to conduct our clinical trials. Our inability to
successfully complete preclinical and clinical development could
result in additional costs to us and negatively impact our ability
to generate revenue. Our future success is dependent on our ability
to successfully develop, obtain regulatory approval for, and then
successfully commercialize product candidates. We currently
generate no revenues from sales of any products, and we may never
be able to develop or commercialize a marketable
product.
We have not yet completed full data results for any Phase 3 trials
for any product candidate. The results of preclinical and early
clinical trials of our product candidates and other products with
the same mechanism of action may not be predictive of the results
of later-stage clinical trials. Clinical trial failure may result
from a multitude of factors including flaws in trial design, dose
selection, placebo effect, patient enrollment criteria, relatively
smaller sample size in earlier trials, and failure to demonstrate
favorable safety or efficacy traits. As such, failure in clinical
trials can occur at any stage of testing. A number of companies in
the biopharmaceutical industry have suffered setbacks in the
advancement of clinical trials due to lack of efficacy or adverse
safety profiles, notwithstanding promising results in earlier
trials, and we cannot be certain that we will not face similar
setbacks. Based upon negative or inconclusive results, we may
decide, or regulators may require us, to conduct additional
clinical trials or preclinical studies. In addition, data obtained
from clinical trials are susceptible to varying interpretations,
and regulators may not interpret our data as favorably as we do,
which may further delay, limit or prevent marketing approval.
Furthermore, as more product candidates within a particular class
of drugs proceed through clinical development to regulatory review
and approval, the amount and type of clinical data that may be
required by regulatory authorities may increase or change. The
outcome of preclinical testing and early clinical trials may not be
predictive of the success of later clinical trials, and preliminary
or interim results of a clinical trial do not necessarily predict
final results. For example, our product candidates may fail to show
the desired safety and efficacy in clinical development despite
positive results in preclinical studies or having successfully
advanced through initial clinical trials. The failure of any of our
product candidates to demonstrate safety and efficacy in any
clinical trial could negatively impact the perception of our other
product candidates or cause regulatory authorities to require
additional testing before approving any of our product
candidates.
We currently have two product candidates in clinical development
and their risk of failure is high. For example, use of TP-03
requires the patient to follow a prescribed technique to administer
the eye drops. Failure to properly administer the eye drops by the
patient or inappropriate technique demonstration by the eye care
practitioners, may adversely affect the outcome of TP-03 in
demonstrating efficacy in one or more clinical trials. We are
unable to predict if this product candidate or any of our future
product candidates that advance into clinical trials will prove
safe or effective in humans or will obtain marketing
approval. If we are unable to complete preclinical or clinical
trials of current or future product candidates, due to safety
concerns, or if the results of these trials are not satisfactory to
convince regulatory authorities of their safety or efficacy, we
will not be able to obtain marketing approval for
commercialization. Even if we are able to obtain marketing
approvals for any of our product candidates, those approvals may be
for indications that are not as broad as desired or may contain
other limitations that would adversely affect our ability to
generate revenue from sales of those products. Moreover, if we are
not able to differentiate our product against other approved
products within the same class of drugs, or if any of the other
circumstances described above occur, our business would be
materially harmed and our ability to generate revenue from that
class of drugs would be severely impaired.
Each of our product candidates will require additional clinical
development, management of clinical, preclinical (for some of our
product candidates) and manufacturing activities, regulatory
approval in multiple jurisdictions, achieving and maintaining
commercial-scale supply, building of a commercial organization,
substantial investment and significant marketing efforts before we
generate any revenues from product sales. We are not permitted to
market or promote any of our product candidates before we receive
regulatory approval from the FDA or comparable foreign regulatory
authorities, and we may never receive such regulatory approval for
any of our product candidates. We may experience delays in our
ongoing clinical trials, and we do not know whether planned
clinical trials will begin on time, need to be redesigned, enroll
patients on time or be completed on schedule, if at all. For
example, the FDA had initially recommended that for TP-03 we
conduct carcinogenicity testing and has subsequently agreed in Type
C meeting minutes that we can submit a carcinogenicity waiver, and
if not granted, the carcinogenicity testing could be conducted and
submitted as a post-marketing requirement. Furthermore, the FDA
recommended that we conduct embryofetal development studies in a
second species, which have been completed. Any further
recommendations by the FDA could cause delay of any regulatory
approval by the FDA and cause our expenses to increase. We may
experience numerous unforeseen events during, or as a result of,
clinical trials that could delay or prevent our ability to receive
marketing approval or commercialize TP-03, our other product
candidates, or any other product candidates that we may develop,
including:
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we may experience delays in or failure to reach agreement on
acceptable terms with prospective CROs, vendors and clinical sites,
the terms of which can be subject to extensive negotiation and may
vary significantly among different CROs, vendors and trial
sites;
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we may fail to obtain sufficient enrollment in our clinical trials,
our enrollment needs may grow larger than we anticipate, or
participants may fail to complete our clinical trials at a higher
rate than we anticipate;
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clinical trials of our product candidates may produce negative or
inconclusive results, and we may decide, or regulators may require
us, to conduct additional clinical trials or abandon product
development programs;
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we may decide, or regulators or institutional review boards or
ethics committees may require us, to suspend or terminate clinical
research for various reasons, including noncompliance with
regulatory requirements or a finding that the participants are
being exposed to unacceptable health risks;
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regulators or institutional review boards or ethics committees may
not authorize us or our investigators to commence a clinical trial
at a prospective clinical trial site or at all or may require us to
perform additional or unanticipated clinical trials to obtain
approval or we may be subject to additional post-marketing testing
requirements to maintain regulatory approval;
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regulators may revise the requirements for approving our product
candidates, or such requirements may not be as we
anticipate;
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the cost of clinical trials of our product candidates may be
greater than we anticipate, and we may need to delay or suspend one
or more trials until we complete additional financing transactions
or otherwise receive adequate funding;
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the supply or quality of our product candidates or other materials
necessary to conduct clinical trials of our product candidates may
be insufficient or inadequate or may be delayed;
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our product candidates may have undesirable side effects or other
unexpected characteristics, causing us or our investigators,
regulators or institutional review boards or ethics committees to
suspend or terminate trials;
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regulatory authorities may determine that the planned design of our
clinical trials is flawed or inadequate;
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regulatory authorities may suspend or withdraw their approval of a
product or impose restrictions on its distribution;
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we may not be able to timely or at all obtain Investigational New
Drug ("IND") treatment for a product candidate;
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we may modify a preclinical study or clinical trial
protocol;
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third-party contractors may fail to comply with regulatory
requirements or meet their contractual obligations to us in a
timely manner, or at all;
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we may be unable to establish clinical endpoints that applicable
regulatory authorities consider clinically meaningful, or, if we
seek accelerated approval, biomarker efficacy endpoints that
applicable regulatory authorities consider likely to predict
clinical benefit;
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we may experience delays due to the ongoing COVID-19 pandemic,
including with respect to the conduct of ongoing clinical trials,
receipt of product candidates or other materials, submission of
NDAs, filing of IND applications, and starting any clinical trials
for other indications or programs; and
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we may experience manufacturing delays due to the recent COVID-19
pandemic in our supply chain caused by a shortage of raw materials,
a lack of employees on site at our suppliers due to illness, or a
lack of productivity at our suppliers due to local or national
government quarantine restrictions on coming to the
workplace.
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If we are required to conduct additional clinical trials or other
testing of our product candidates beyond those that we currently
contemplate, if we are unable to successfully complete clinical
trials of our product candidates or other testing, if the results
of these trials or tests are not positive or are only modestly
positive, if there are safety concerns or if we determine that the
observed safety or efficacy profile would not be competitive in the
marketplace, we may:
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be delayed in obtaining marketing approval for our product
candidates;
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not obtain marketing approval at all;
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obtain marketing approval in some countries and not in
others;
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obtain approval for indications or patient populations that are not
as broad as intended or desired;
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obtain approval with labeling that includes significant use or
distribution restrictions or safety warnings;
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be subject to additional post-marketing testing requirements;
or
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have the product removed from the market after obtaining marketing
approval.
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We cannot be certain whether any of our planned clinical trials
will begin on schedule or any preclinical studies we plan to
initiate will begin on our intended schedule, or whether any such
studies or clinical trials will need to be restructured or will be
completed on schedule, or at all. If we experience delays in the
completion of, or termination of, any clinical trial of our product
candidates, or are unable to achieve clinical endpoints due to
unforeseen events, such as the COVID-19 pandemic, the commercial
prospects of our product candidates will be harmed, and our ability
to generate product revenues from any of these product candidates
will be delayed. In addition, any delays in completing our clinical
trials will increase our costs, slow down our product candidate
development and approval process and jeopardize our ability to
commence product sales and generate revenues. Significant clinical
trial delays could also allow our competitors to bring products to
market before we do or shorten any periods during which we have the
exclusive right to commercialize our product candidates and impair
our ability to commercialize our product candidates and may harm
our business and results of operations.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
Use of Proceeds from Initial Public Offering
There has been no material change in the planned use of proceeds
from our IPO as described in the Registration Statement on Form S-1
(File No. 333-249076), declared effective by the SEC on October 15,
2020, and the related final prospectus, dated October 15, 2020,
filed with the SEC on October 16, 2020, pursuant to Rule 424(b) of
the Securities Act.
Item 3. Defaults Upon Senior Securities.
None.
Item 4. Mine Safety Disclosures.
None.
Item 5. Other Information.
None.
Item 6. Exhibits
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Exhibit
Number |
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Description |
Form |
File Number |
Incorporated by Reference Exhibit |
Date |
Filed Herewith |
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10.1 |
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X |
10.2 |
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X |
31.1 |
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X |
31.2 |
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X |
32.1* |
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X |
32.2* |
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X |
101.INS |
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Inline XBRL Instance Document - The instance document does not
appear in the interactive data file because its XBRL tags are
embedded within the inline XBRL document. |
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X |
101.SCH |
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Inline XBRL Taxonomy Extension Schema Document. |
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X |
101.CAL |
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Inline XBRL Taxonomy Extension Calculation Linkbase
Document. |
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X |
101.DEF |
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Inline XBRL Taxonomy Extension Definition Linkbase
Document. |
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X |
101.LAB |
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Inline XBRL Taxonomy Extension Label Linkbase Document. |
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X |
101.PRE |
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Inline XBRL Taxonomy Extension Presentation Linkbase
Document. |
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X |
104 |
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Cover Page Interactive Data File (formatted as Inline XBRL and
contained in Exhibit 101). |
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X |
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*
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The certifications attached as Exhibit 32.1 and 32.2 that accompany
this Quarterly Report on Form 10-Q are not deemed filed with the
Securities and Exchange Commission and are not to be incorporated
by reference into any filing of Tarsus Pharmaceuticals, Inc. under
the Securities Act of 1933, as amended, or the Securities Exchange
Act of 1934, as amended, whether made before or after the date of
this Quarterly Report on Form 10-Q, irrespective of any general
incorporation language contained in such filing. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of
1934, as amended, the Registrant has duly caused this report to be
signed on its behalf by the undersigned, thereunto duly
authorized.
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TARSUS PHARMACEUTICALS, INC. |
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/s/ Bobak Azamian, M.D., Ph.D. |
Bobak Azamian, M.D., Ph.D. |
President and Chief Executive Officer |
(Principal Executive Director) |
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/s/ Leonard M. Greenstein |
Leonard M. Greenstein |
Chief Financial Officer |
(Principal Financial Officer and Principal Accounting
Officer) |
Tarsus Pharmaceuticals (NASDAQ:TARS)
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